## Protocol Section
### Identification Module
**NCT ID:** NCT06424327

**Brief Title:** A Registry for People With Lung Cancer

**Official Title:** Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108

#### Organization Study ID Info
**ID:** 24-127
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
### Status Module
#### Completion Date
**Date:** 2029-05-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2029-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Memorial Sloan Kettering Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.

### Conditions Module

**Conditions:**

- Lung Cancer

- Lung Cancer Stage I

**Keywords:**

- lung cancer

- lung cancer stage 1

- segmentectomy

- Memorial Sloan Kettering Cancer Center

- 24-127

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants undergoing planned pulmonary segmentectomy for primary lung cancer

**Intervention Names:**

- Other: Patient-Reported Outcomes Measurement Information System

**Label:** Participants with Lung Cancer

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participants with Lung Cancer

**Description:** Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PROMIS bank version 1.1), and dyspnea severity (PROMIS bank version 1.0)

**Name:** Patient-Reported Outcomes Measurement Information System

**Other Names:**

- PROMIS

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** DFS is measured from the date of surgery to the date of recurrence or death

**Measure:** Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.

**Time Frame:** 3 years

**Description:** DFS is measured from the date of surgery to the date of recurrence or death

**Measure:** Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years
* Clinical stage I tumor (AJCC 8th edition) suitable for segmentectomy, according to the treating thoracic surgeon
* Pathology of NSCLC

  o Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology.
* Patients must undergo segmentectomy for a peripheral lesion ≤2 cm to be included in the primary analysis. Individual ligation of the segmental artery(s) and segmental bronchus is the minimum definition for a segmentectomy. Division of the segmental vein and intraoperative frozen section to assess surgical margins and N1 lymph nodes are strongly encouraged, but the absence of either is not a criterion for exclusion.

Other considerations:

* Patients with ground-glass opacities will have their tumor size recorded on the basis of the size of the solid component.
* Any non-lung cancer treated in the past with no obvious recurrence or ongoing treatment is not a criterion for exclusion.
* The registry study will be monitored by Thoracic Surgery team at MSK.
* This study will be in collaboration with the Thoracic Surgical Oncology Group (TSOG) of the American Association for Thoracic Surgery.

Exclusion Criteria:

* Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
* History of chemotherapy or radiation therapy for a previous lung cancer
* Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
* Carcinoid tumors
* History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
* Actively receiving treatment for other malignancies
* Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.

  * Multi-segmental resection from the same lobe is not a criterion for exclusion.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All study subjects will be recruited from their respective clinics (i.e., Thoracic Surgery, Pulmonary, Survivorship, etc.) at participating sites. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team by screening patients' medical records. If eligible, the study will be discussed with each patient.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jonesd2@mskcc.org

**Name:** David Jones, MD

**Phone:** 212-639-6428

**Role:** CONTACT

**Contact 2:**

**Email:** parkb@mskcc.org

**Name:** Bernard Park, MD

**Phone:** 646-888-3346

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Basking Ridge

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 07920

**Location 2:**

**City:** Middletown

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 07748

**Location 3:**

**City:** Montvale

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Bergen (Limited Protocol Activities)

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 07645

**Location 4:**

**City:** Commack

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

**State:** New York

**Status:** RECRUITING

**Zip:** 11725

**Location 5:**

**City:** Harrison

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Westchester (Limited Protocol Activities)

**State:** New York

**Status:** RECRUITING

**Zip:** 10604

**Location 6:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

***Contact 2:***

- **Name:** Yuan Liu, MD, PhD

- **Phone:** 646-888-3640

- **Role:** CONTACT

***Contact 3:***

- **Name:** David Jones, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Memorial Sloan Kettering Cancer Center (All Protocol Activities)

**State:** New York

**Status:** RECRUITING

**Zip:** 10065

**Location 7:**

**City:** Uniondale

**Contacts:**

***Contact 1:***

- **Name:** David Jones, MD

- **Phone:** 212-639-6428

- **Role:** CONTACT

**Country:** United States

**Facility:** Memorial Sloan Kettering Nassau (Limited Protocol Activities)

**State:** New York

**Status:** RECRUITING

**Zip:** 11553

#### Overall Officials

**Official 1:**

**Affiliation:** Memorial Sloan Kettering Cancer Center

**Name:** David Jones, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

**IPD Sharing:** YES

### References Module

#### See Also Links

**Label:** Memorial Sloan Kettering Cancer Center

**URL:** http://www.mskcc.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
