A Registry for People With Lung Cancer

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

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

Study Overview

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network (Data Collection Only)
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Recruiting
        • Centre Hospitalier de l'Université de Montreal (Data Collection Only)
        • Contact:
          • Moishe Liberman, MD. PhD
          • Phone Number: 514-890-8000, ext: 26832
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona (Data Collection Only)
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 606012
        • Recruiting
        • Rush University Medical Center (Data collection only)
        • Contact:
          • Christopher Seder, MD
          • Phone Number: 312-738-3732
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health
        • Contact:
          • Seth Krantz, MD
          • Phone Number: 847-570-2868
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan (Data Collection Only)
        • Contact:
          • Jules Lin, MD
          • Phone Number: 734-936-8857
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Yuan Liu, MD, PhD
          • Phone Number: 646-888-3640
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
        • Principal Investigator:
          • David Jones, PhD
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • David Jones, MD
          • Phone Number: 212-639-6428
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • ALLEGHENY HEALTH NETWORK (Data Collection Only)
        • Contact:
          • Benny Weksler, MD
          • Phone Number: 412-359-6137
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center (Data Collection Only)
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center (Data Collection Only)
        • Contact:
          • David Rice, MD
          • Phone Number: 800-392-1611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Clinical Stage I with suspected NSCLC, classified preoperatively based on the AJCC TNM staging manual, 9th edition o Note: 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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with Lung Cancer
Participants undergoing planned pulmonary segmentectomy for primary lung cancer
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)
Other Names:
  • PROMIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
Time Frame: 3 years
DFS is measured from the date of surgery to the date of recurrence or death
3 years
Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
Time Frame: 5 years
DFS is measured from the date of surgery to the date of recurrence or death
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Jones, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

May 15, 2029

Study Completion (Estimated)

May 15, 2029

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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