Clinical trial NCT06424327: A Registry for People With Lung Cancer
Official title: Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung Cancer Stage I
Keywords: lung cancer
lung cancer stage 1
segmentectomy
Memorial Sloan Kettering Cancer Center
24-127
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
timeFrame: 3 years
measure: Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan (Data Collection Only)
state: Michigan
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: