## Protocol Section
### Identification Module
**NCT ID:** NCT01753479

**Brief Title:** Spectroscopy From Duodenum

**Official Title:** Duodenal Spectroscopy Study for Cancer Diagnosis

#### Organization Study ID Info
**ID:** OMSC-Mag-1
#### Organization
**Class:** INDUSTRY
**Full Name:** Olympus Corporation
### Status Module
#### Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-07

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-06-30

**Type:** ACTUAL

#### Start Date
**Date:** 2013-01

**Type:** ACTUAL

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2012-12-20
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-17
**Study First Submit QC Date:** 2012-12-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

**Class:** OTHER

**Name:** Catholic University of the Sacred Heart

**Class:** OTHER

**Name:** Erasme University Hospital

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Olympus Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

**Detailed Description:** Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis. Therefore this study can be positioned as a feasibility study.

### Conditions Module

**Conditions:**

- Pancreatic Adenocarcinoma

**Keywords:**

- Pancreatic adenocarcinoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 445

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Spectroscopy device

**Label:** Test subject

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test subject

**Description:** Spectrum data are collected using spectroscopy device via an instrumental channel of endoscope. Then spectrum data is analyzed. Numerical features (spectral slope and width of spectrum) are used for statistical analysis.

**Name:** Spectroscopy device

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** To clarify that there is the statistically-significant difference between two cohorts.

**Measure:** The spectral data of the normal cohort and UICC stage II pancreatic ductal adenocarcinoma cohort

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** A receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.

**Measure:** The sensitivity and specificity to detect UICC stage II pancreatic ductal adenocarcinoma among all participants.

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Common inclusion criterion

  * Age is 18 years or older.
  * Informed consent was obtained.
  * Inclusion criterion for normal cohort
  * An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  * No findings of pancreatic disorder as documented by CT or MRI or EUS
* Inclusion criterion for PC suspicious cohort \* A EUS or ERCP is scheduled to suspected pancreatic disorder.

Exclusion Criteria:

* Common exclusion criterion

  * Severe cardiac disease
  * Severe respiratory disease
  * Bleeding disorders
  * Pregnancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Jacksonville

**Country:** United States

**Facility:** Mayo Clinic Florida

**State:** Florida

**Zip:** 32224

**Location 2:**

**City:** Houston

**Country:** United States

**Facility:** The University of Texas M. D. Anderson Cancer Center

**State:** Texas

**Zip:** 77030

**Location 3:**

**City:** Bruxelles

**Country:** Belgium

**Facility:** Hôpital Erasme

**State:** Brussels-Capital Region

**Zip:** 1070

**Location 4:**

**City:** Rome

**Country:** Italy

**Facility:** Università Cattolica del Sacro Cuore

**State:** Lazio

**Zip:** 00168

#### Overall Officials

**Official 1:**

**Affiliation:** Mayo Clinic

**Name:** Michael B Wallace, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3585

- Name: Adenocarcinoma

- Relevance: HIGH

- As Found: Adenocarcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000230

- Term: Adenocarcinoma

### Misc Info Module

- Version Holder: 2024-05-24
