Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT02360761
Eligibility Criteria:
Inclusion Criteria:
* Aged 70 years or older
* Preoperative criteria (contrast-enhanced Computed tomography scan)
* Suspected non-small cell lung cancer
* Clinical stage ⅠA, i.e. T1N0M0 (tumor diameter ≤3 cm, surrounded by visceral pleura, short-axis of lymph node \<1 cm or cold lymph nodes on PET scan)
* The maximum diameter of consolidation of the maximum tumor diameter (consolidation/tumor ratio, C/T ratio) is no less than 0.5 in sub-solid lesions
* Eligible for sublobar resection with sufficient margin
* Intraoperative criteria
* Histologically confirmed invasive NSCLC, i.e. NSCLC other than pre-invasive adenocarcinomas defined by The International Association for the Study of Lung Cancer (adenocarcinoma in situ, and minimally invasive adenocarcinoma)
* Pathological exclusion of suspected lymph nodes involvement
* Feasible to perform sublobar resection in terms of surgical margin requirement
* General criteria
* Must sign informed consent by the patient or his/her entrusted party
* Must complete 4-year mortality index and comprehensive geriatric assessment(CGA) if necessary
* The physiological reservation can tolerate lobectomy
Exclusion Criteria:
* Unable to comply with the study procedure
* Past thoracic surgery history, except for diagnostic thoracoscopy
* Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma, and uterine cervix cancer in situ
* Any active systemic diseases including uncontrolled hypertension, unstable angina pectoris, newly onset of angina pectoris within recent 3 months, congestive heart failure (class II or plus of New York Heart Association, NYHA), myocardial infarction within recent 6 months, severe disease in the need of medication such as arrhythmia, liver, renal or metabolic diseases
* Uncontrollable infections
* Coexisting small cell lung cancer
* Psychiatric diseases diagnosed
* Other circumstances which is deemed inappropriate for enrollment by the researchers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT02360761
Study Brief:
Protocol Section:
NCT02360761