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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT02502318
Eligibility Criteria:
Inclusion Criteria:
* Patients who have given their consent
* Any patient with proven or suspected lung cancer treated by lobectomy or segmentectomy.
* Patients with a negative mediastinoscopy or negative " EBUS-EUS " following a PET scan showing uptake in mediastinal lymph nodes in the preoperative examination.
* Age ≥ 18 years
* Patient affiliated to a social security regimen
* Patients with a WHO performance status equal to 0 or 1.
Exclusion Criteria:
* Adults under wardship
* Pregnant or breast-feeding women
* Tumours in contact with the pulmonary artery or developing in the lobar bronchi after bronchial fibroscopy.
* Tumours in contact with the costal periosteum or invading the chest wall
* Tumours invading the mediastinal pleura or structures of the mediastinium (superior vena cava, trachea, the main-stem bronchi, aorta, oesophagus, vertebrae)
* Tumours invading the diaphragm
* Tumours invading the neurovascular structures of the apex (brachial plexus, subclavicular artery, subclavicular vein) causing Pancoast-Tobias syndrome
* Patients with histologically-proven contralateral or supraclavicular lymph node (N3) involvement whatever the harvesting method.
* Patients with a positive mediastinoscopy or positive "EBUS-EUS" following a "PET scan" with uptake in one or more mediastinal lymph nodes.
* Patients with metastasis (brain, bone, liver, adrenal glands, contralateral lung, pleura).
* Patients who have undergone neo-adjuvant chemotherapy and/or radiotherapy.
* Patients included in a neo-adjuvant chemotherapy and/or radiotherapy protocol.
* Patients who have already undergone thoracotomy.
* Patients with decompensated heart failure or with a systolic ejection fraction below 30%.
* Patients with severe pulmonary artery hypertension.
* Patients with untreated valve disease.
* Patients with unstable angina despite appropriate treatment.
* Patients with untreated carotid stenosis greater than 70%.
* Patients with histologically proven cirrhosis with various decompensations or who have presented haemoptysis because of oesophageal varicose veins.
* Patients with severe neurological sequellae (hemiplegia, paraplegia, tetraplegia).
* Patients presenting severe psychiatric disorders (dementia, psychosis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02502318
Study Brief:
Protocol Section:
NCT02502318