RecruitingNCT06424327

A Registry for People With Lung Cancer

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

600 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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.

Interventions

OTHERPatient-Reported Outcomes Measurement Information System

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)


Locations(15)

Rush University Medical Center (Data collection only)

Chicago, Illinois, United States

Endeavor Health

Evanston, Illinois, United States

University of Michigan (Data Collection Only)

Ann Arbor, Michigan, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

Thomas Jefferson University Hospital (Data Collection Only)

Philadelphia, Pennsylvania, United States

ALLEGHENY HEALTH NETWORK (Data Collection Only)

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, United States

University Health Network (Data Collection Only)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06424327


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