A Registry for People With Lung Cancer

Recruiting

• Conditions: Lung Cancer; Lung Cancer Stage I
• Interventions: Other: Patient-Reported Outcomes Measurement Information System

• Registration Number: NCT06424327
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2029-05-15
• Study Completion: 2029-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age ≥18 years

• Clinical stage I tumor (AJCC 8th edition) suitable for segmentectomy, according to the treating thoracic surgeon

  o Note: 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.

• 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.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Lung Cancer	Patient-Reported Outcomes Measurement Information System	Participants undergoing planned pulmonary segmentectomy for primary lung cancer

Primary Outcome Measures

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

Trial Locations

Locations (8)

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 Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States