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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT04371458
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group - PS 0 or 1
* Patients with a histologic diagnosis of thymic epithelial tumor (thymoma WHO type A, AB, B1, B2, B3; or thymic carcinoma) who in the opinion of the attending thoracic surgeon can technically receive a macroscopic complete resection of pleural nodules. This histologic diagnosis can be obtained either preoperatively, or based on frozen section intra-operatively.
* Signed informed consent form
* Completely resectable burden of disease
* No evidence of distant organ metastasis except resectable pulmonary parenchymal nodules and intrathoracic lymph node metastasis as evidenced by CT chest, physical examination, and any other indicated studies
* Medically suitability for resection as determined by the operating surgeon
* Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test pre-operatively
Exclusion Criteria:
* Patients with active invasive cancers, other than thymoma, that requires treatment, except non-melanomatous skin cancer, superficial bladder cancer or cervical cancer and early stage prostate cancer.
* If frozen section reveals a diagnosis other than thymoma or thymic carcinoma, the patient will be removed from protocol and the providone-iodine lavage will not be performed.
* Hyperthyroidism or Radioisotope treatment for thyroid disease.
* Radiographic evidence of disease beyond the primary site and pleural space
* History of pulmonary resection more than lobectomy. (regardless of laterality)
* Pregnant or lactating patients
* Patients with iodine allergy
* Patients who have severe liver disease including cirrhosis, grade III-IV elevations in liver function studies, or bilirubin in excess of 1.5 mg/decilitre
* Pulmonary nodules or visceral nodules requiring pulmonary resection sacrificing more than half of ipsilateral lung parenchyma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04371458
Study Brief:
Protocol Section:
NCT04371458