Eligibility Module

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: 2025-12-25 @ 12:34 AM
Ignite Modification Date: 2025-12-25 @ 12:34 AM
NCT ID: NCT00002667
Eligibility Criteria: DISEASE CHARACTERISTICS: Stage I (T1-2 N0) nonsmall cell lung cancer curatively resected and in regular follow-up for at least 6 weeks Material available for histologic review At least 1 mediastinal node station sampled or at least 2 years since surgery Any of the following histologies eligible: Squamous cell carcinoma Large cell carcinoma Adenocarcinoma (including bronchoalveolar) No small cell anaplastic component No recurrent disease or second primary No synchronous lung cancer of a different histology Concurrent registration on intergroup protocol I91-0001 allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Cardiovascular: No history of severe hypertension, i.e.: Systolic 200 mm Hg or more Diastolic 120 mm Hg or more No MI within 6 weeks Pulmonary: Available for annual sputum induction and clinical evaluation Clinically able to undergo pulmonary function tests (PFTs) and bronchoscopy Refusal of PFTs or bronchoscopy will not effect eligibility PFTs waived if FEV1/FVC \< 65% on prior testing No acute respiratory infection Other: No prior uncontrolled malignancy except nonmelanomatous skin cancer Exceptions for malignancy controlled more than 5 years discretionary PRIOR CONCURRENT THERAPY: Complete surgical resection required as primary therapy At least 6 weeks since resection, any adjuvant chemotherapy or radiotherapy, or thoracoabdominal surgery
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Maximum Age: 120 Years
Study: NCT00002667
Study Brief:
Protocol Section: NCT00002667