## Protocol Section
### Identification Module
**NCT ID:** NCT03648879

**Brief Title:** Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome

**Official Title:** Phase II Study Evaluating Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome

#### Organization Study ID Info
**ID:** 180141
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 18-C-0141
### Status Module
#### Completion Date
**Date:** 2020-05-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-12

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-04-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-03-25

**Type:** ACTUAL

**Results First Submit Date:** 2021-03-02

**Results First Submit QC Date:** 2021-03-02

#### Start Date
**Date:** 2019-02-11

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2018-08-28
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-24
**Study First Submit QC Date:** 2018-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Responsible Party

**Investigator Affiliation:** National Cancer Institute (NCI)

**Investigator Full Name:** Jeremy Davis, M.D.

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Background:

People with hereditary gastric cancer syndrome are at increased risk of getting cancer in their stomach. These people should have regular endoscopies and biopsies to check for cancer if they are choosing to keep their stomach. Researchers want to see if they can improve the detection of cancer by endoscopy. Improved endoscopies could better detect early signs of cancer in people with this syndrome.

Objective:

To see if a small microscope attached to an endoscope to inspect the stomach lining is better than regular endoscopy to find the first signs of cancer in the stomach.

Eligibility:

People ages 18 and older who have a personal or family history of a hereditary gastric cancer syndrome or have a mutation that is known to lead to gastric cancer

Design:

Participants will be screened over the phone or in person with:

* Personal and family medical history
* Review of their medical records

Participants will have a physical exam. Then they will be put under general anesthesia. They will have an endoscopy. A lighted tube will be inserted into the mouth and go down to the stomach. First, the standard device will be used. Then participants will be injected with fluorescein. This is a contrast agent. Then the microscope will be added to the tube and the endoscopic evaluation of the stomach will be repeated. During the procedure, biopsies will be taken from different areas of the stomach. Participants will be observed for a few hours after the procedure.

About 14 days after the endoscopy, participants will be asked to return to the clinic for a follow-up visit. This visit can also be conducted over the phone.

**Detailed Description:** Background:

Hereditary Diffuse Gastric Cancer (HDGC) syndrome is caused by a germline mutation in the Cadherin 1 (CDH1) gene. Carriers of this mutation have a 56-70% lifetime risk of developing gastric adenocarcinoma. Current international guidelines recommend endoscopic screening of CDH1 mutation carriers that consists of systematic biopsies of an otherwise normal appearing stomach. However, this approach lacks sufficient sensitivity for detecting intramucosal foci of signet ring cells (SRC), which are pathognomonic of HDGC syndrome. The goal of the current study is to utilize confocal endoscopic microscopy (CEM) for screening the gastric mucosa in this high-risk population.

Objective:

Determine if confocal endoscopic microscopy (CEM) will afford greater sensitivity for detection of signet ring cells (SRC) foci in CDH1 germline mutation carriers.

Eligibility:

CDH1 germline mutation carriers, or those who meet clinical criteria for HDGC testing but have tested negative for a CDH1 gene mutation or those who have other germline mutations suspected to be, or reported to be, associated with HDGC (e.g. Catenin Alpha 1 (CTNNA1).

Design:

Phase II, single-institution study of CEM for detection of intramucosal SRC foci compared to current systematic gastric mapping procedure.

### Conditions Module

**Conditions:**

- Gastric Cancer

- Gastric Neoplasms

**Keywords:**

- Diagnostic

- Diagnosis

- EGD

- Examination of Stomach

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 37

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

**Intervention Names:**

- Device: Endoscope+Cellvizio(R) 100 microscope

**Label:** 1/Arm 1 - Upper white-light endoscopy and confocal endoscopic microscopy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1/Arm 1 - Upper white-light endoscopy and confocal endoscopic microscopy

**Description:** Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.

**Name:** Endoscope+Cellvizio(R) 100 microscope

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

**Measure:** Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

**Time Frame:** Date of enrollment to date off study, approximately 11 months and 19 days.

#### Primary Outcomes

**Description:** Sensitivity for detection of SRC foci in CDH1 germline mutation carriers was assessed by confocal endoscopic microscopy (CEM) compared to the current method of and standard white light endoscopy.

Sensitivity in CEM and WLE is defined as the percentage of participants with detectable cancer on endoscopic biopsy.

**Measure:** Percentage of Participants With Detectable Confocal Endoscopic Microscopy (CEM) w/Greater Sensitivity for Detection of Signet Ring Cells (SRC)Foci in Cadherin-1 (CDH1) Germline Mutation Carriers Compared to Current Method of Standard White Light Endoscopy

**Time Frame:** 14 days

#### Secondary Outcomes

**Description:** In participants who choose to undergo prophylactic total gastrectomy with permanent pathologic analysis, the false negative rate (the fraction of participants who have SRC foci not identified by CEM and White Light Endoscopy techniques) will be determined and reported. The fraction percentage of patients who underwent prophylactic total gastrectomy with findings of SRC foci in the gastrectomy specimen will represent the denominator (number) and the number of patients with negative findings by CEM and White Light Endoscopy (WLE) will represent the numerator (number) to generate the false negative detection rate (fraction) for CEM and WLE, respectively.

**Measure:** Percentage of Participants Who Have Signet Ring Cells (SRC) Foci Not Identified by Confocal Endoscopic Microscopy (CEM)

**Time Frame:** Date of enrollment to date of prophylactic gastrectomy, approximately 6 months or an average of 1 month up to 12 months.

### Eligibility Module

**Eligibility Criteria:** * INCLUSION CRITERIA:
* Patients with Cadherin-1 (CDH1) germline mutation known to be pathogenic or likely pathogenic, which may also be classified as "significant" or "likely significant" (patients with variants of "uncertain significance " are excluded)

or

-Patients with Catenin Alpha 1 (CTNNA1) and partner and localizer of breast cancer 2 (BRCA2) (PALB2) germline mutations suspected to be, or reported to be, associated with hereditary diffuse gastric cancer (HDGC) syndrome.

or

* In the absence of a germline CDH1 mutation, patients must meet clinical criteria for genetic testing due to a history suggestive of Hereditary Diffuse Gastric Cancer (HDGC) syndrome
* Age greater than or equal to 18 years.
* Physiologically able to undergo upper endoscopy.
* Ability to understand and the willingness to sign a written informed consent document.
* Pregnant women are eligible during second trimester of pregnancy if clinically indicated for evaluation of cancer.

EXCLUSION CRITERIA:

* Current use of therapeutic anticoagulation medication
* Known bleeding disorder or thrombocytopenia.
* Unstable angina or recent (within 3 months) myocardial infarction
* Any clinical contraindication to general anesthesia

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bethesda

**Country:** United States

**Facility:** National Institutes of Health Clinical Center

**State:** Maryland

**Zip:** 20892

#### Overall Officials

**Official 1:**

**Affiliation:** National Cancer Institute (NCI)

**Name:** Jeremy L Davis, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Requests must be made by clinical investigators with interest and/or expertise in gastrointestinal cancers or endoscopic surveillance techniques.

**Description:** We will share the study protocol, statistical analysis plan, and clinical study report.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** For 2 years from date of study completion.

### References Module

#### References

**Citation:** Schueler SA, Gamble LA, Curtin BF, Ruff SM, Connolly M, Hannah C, Quezado M, Miettinen M, George M, Blakely AM, Hernandez JM, Heller T, Koh C, Davis JL. Evaluation of confocal laser endomicroscopy for detection of occult gastric carcinoma in CDH1 variant carriers. J Gastrointest Oncol. 2021 Apr;12(2):216-225. doi: 10.21037/jgo-20-430.

**PMID:** 34012620

**Citation:** Ruff S, Curtin B, Quezado M, Heller T, Koh C, Steinberg SM, Connolly M, Hernandez JM, Davis JL. Evaluation of confocal endoscopic microscopy for detection of early-stage gastric cancer in hereditary diffuse gastric cancer (HDGC) syndrome. J Gastrointest Oncol. 2019 Jun;10(3):407-411. doi: 10.21037/jgo.2019.01.04.

**PMID:** 31183189

#### See Also Links

**Label:** NIH Clinical Center Detailed Web Page

**URL:** https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2018-C-0141.html

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-06-05

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 643239

- Type Abbrev: Prot_SAP

- Upload Date: 2021-01-12T11:59

- Date: 2019-07-22

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 201265

- Type Abbrev: ICF

- Upload Date: 2021-01-12T12:01

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: T1863

- Name: Diffuse Gastric Cancer

- Relevance: HIGH

- As Found: Diffuse Gastric Cancer

- ID: T2744

- Name: Hereditary Diffuse Gastric Cancer

- Relevance: HIGH

- As Found: Hereditary Diffuse Gastric Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** 36/37 were evaluable for adverse events. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.

#### Event Groups

**Group ID:** EG000

**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy

**Deaths Num At Risk:** 36

**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 36

**Serious Number At Risk:** 36

**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy

**Frequency Threshold:** 0

#### Other Events

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (5.0)

**Term:** Urinary Tract Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** CTCAE (5.0)

**Time Frame:** Date of enrollment to date off study, approximately 11 months and 19 days.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 37

**Units:** Participants

### Group

**ID:** BG000

**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy

**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 30

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14.02

**Value:** 50.51

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Class Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 31

**Class Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Ethnicity Unknown or Not Reported

#### Measurement

**Group ID:** BG000

**Value:** 33

**Class Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Race Other

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Race Unknown

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 37

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** jeremy.davis@nih.gov
**Organization:** National Cancer Institute
**Phone:** 240-760-6229
**Title:** Dr. Jeremy L. Davis
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 87
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Sensitivity for detection of SRC foci in CDH1 germline mutation carriers was assessed by confocal endoscopic microscopy (CEM) compared to the current method of and standard white light endoscopy.

Sensitivity in CEM and WLE is defined as the percentage of participants with detectable cancer on endoscopic biopsy.
**Parameter Type:** NUMBER
**Population Description:** 36/37 were evaluable for this outcome measure. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.
**Reporting Status:** POSTED
**Time Frame:** 14 days
**Title:** Percentage of Participants With Detectable Confocal Endoscopic Microscopy (CEM) w/Greater Sensitivity for Detection of Signet Ring Cells (SRC)Foci in Cadherin-1 (CDH1) Germline Mutation Carriers Compared to Current Method of Standard White Light Endoscopy
**Type:** PRIMARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
**ID:** OG000
**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy
#### Outcome Measure 2
**Description:** In participants who choose to undergo prophylactic total gastrectomy with permanent pathologic analysis, the false negative rate (the fraction of participants who have SRC foci not identified by CEM and White Light Endoscopy techniques) will be determined and reported. The fraction percentage of patients who underwent prophylactic total gastrectomy with findings of SRC foci in the gastrectomy specimen will represent the denominator (number) and the number of patients with negative findings by CEM and White Light Endoscopy (WLE) will represent the numerator (number) to generate the false negative detection rate (fraction) for CEM and WLE, respectively.
**Parameter Type:** NUMBER
**Population Description:** 36/37 were evaluable for this outcome measure. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.
**Reporting Status:** POSTED
**Time Frame:** Date of enrollment to date of prophylactic gastrectomy, approximately 6 months or an average of 1 month up to 12 months.
**Title:** Percentage of Participants Who Have Signet Ring Cells (SRC) Foci Not Identified by Confocal Endoscopic Microscopy (CEM)
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
**ID:** OG000
**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy
#### Outcome Measure 3
**Description:** Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 36/37 were evaluable for this outcome measure. One participant was determined to have Cadherin-1 (CDH1) variant of uncertain significance.
**Reporting Status:** POSTED
**Time Frame:** Date of enrollment to date off study, approximately 11 months and 19 days.
**Title:** Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** Participants
##### Group
**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
**ID:** OG000
**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy
### Participant Flow Module
#### Group
**Description:** Upper white-light endoscopy and confocal endoscopic microscopy

Endoscope+Cellvizio(R) 100 microscope: Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
**ID:** FG000
**Title:** 1/Arm 1 - Upper White-light Endoscopy and Confocal Endoscopic Microscopy
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Subject determined to have Cadherin-1 (CDH1) variant of uncertain significance.
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 36
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True