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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT02481661
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-70y
2. Preoperative criteria:
ⅰ)Center of tumor is located in the outer third of the lung field, and the maximal diameter ≤ 2 cm(including coronal, traverse and sagittal view) confirmed by 1mm thin layer contrast-enhanced CT scan.
ⅱ)no hilar and mediastinal lymph node metastasis verified by mediastinoscope/EBUS.
3. Intraoperative criteria:
ⅰ)Adenocarcinama or squamous cell carcinoma of lung confirmed by frozen section.
ⅱ)Lobectomy, single segmentectomy or combined segmentectomy is feasible.
ⅲ)Confirmation of N0 status by frozen section examination of nodal levels 10 and 13 for segmentectomy, and 10 for lobectomy.
4. ECOG performance status 0-2.
5. No other malignancy within the past 3 years( except for well prognostic malignancy such as basal cell carcinoma of skin, superficial bladder cancer, or carcinoma in situ of the cervix).
6. No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).
7. No prior chemotherapy or radiation therapy.
8. Lobectomy is tolerated.
9. Sufficient organ functions.
10. Written informed consent.
Exclusion Criteria:
1. Active bacterial or fungous infection.
2. Simultaneous or metachronous (within the past 5 years) multiple cancers.
3. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema, and can not tolerate lobectomy.
4. Psychosis.
5. Uncontrollable diabetes mellitus.
6. History of severe heart disease.
7. The maximal diameter of GGO≤5mm.
8. N1, N2, or M1a is confirmed postoperatively.
9. Postoperative adjuvant therapy (chemotherapy ,radiotherapy or targeted therapy).
10. Other types of lung cancer such as small cell lung cancer, large cell lung cancer, etc.
11. Confirmation of benign disease by postoperative pathologic examination.
12. Lesion located in the middle lobe.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02481661
Study Brief:
Protocol Section:
NCT02481661