NCT06424327

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started May 2024

Longer than P75 for all trials

Geographic Reach
2 countries

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
May 2024May 2029

Study Start

First participant enrolled

May 15, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2029

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

May 16, 2024

Last Update Submit

February 18, 2026

Conditions

Keywords

lung cancerlung cancer stage 1segmentectomyMemorial Sloan Kettering Cancer Center24-127

Outcome Measures

Primary Outcomes (2)

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

    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.

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

    5 years

Study Arms (1)

Participants with Lung Cancer

Participants undergoing planned pulmonary segmentectomy for primary lung cancer

Other: Patient-Reported Outcomes Measurement Information System

Interventions

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)

Also known as: PROMIS
Participants with Lung Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Rush University Medical Center (Data collection only)

Chicago, Illinois, 606012, United States

RECRUITING

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

University of Michigan (Data Collection Only)

Ann Arbor, Michigan, 48109, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Thomas Jefferson University Hospital (Data Collection Only)

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

ALLEGHENY HEALTH NETWORK (Data Collection Only)

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, 77030, United States

RECRUITING

University Health Network (Data Collection Only)

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Centre Hospitalier de l'Université de Montreal (Data Collection Only)

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • David Jones, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Jones, MD

CONTACT

Bernard Park, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 22, 2024

Study Start

May 15, 2024

Primary Completion (Estimated)

May 15, 2029

Study Completion (Estimated)

May 15, 2029

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Locations