A Registry for People With Lung Cancer

Официальное название

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

Обзор

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

Вмешательства

• Другое Patient-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 (PRO

Первичные конечные точки

• Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Срок оценки: 3 years]
• Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥18 years
• Patients suitable for segmentectomy, according to the treating surgeon
• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 16 центров

• University of Arizona (Data Collection Only) — Tucson
• University of California San Diego (Data collection) — San Diego
• Rush University Medical Center (Data collection only) — Chicago
• Endeavor Health — Evanston
• University of Michigan (Data Collection Only) — Ann Arbor
• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
• … и ещё 8 центров

Канада · 2 центра

• University Health Network (Data Collection Only) — Toronto
• Centre Hospitalier de l'Université de Montreal (Data Collection Only) — Montreal

Идентификаторы

NCT: NCT06424327 · 24-127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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