A Registry for People With Lung Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Lung Cancer Stage I; Lung Cancer

Treatments: Other: Patient-Reported Outcomes Measurement Information System

Study type: Observational

Funder types: Other

Identifiers

NCT06424327

24-127

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 1 patient group

Participants with Lung Cancer

Description:

Participants undergoing planned pulmonary segmentectomy for primary lung cancer

Treatment:

Other: Patient-Reported Outcomes Measurement Information System