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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT04928950
Eligibility Criteria:
Inclusion Criteria:
* Suspected or confirmed diagnosis of lung cancer (non-small cell lung cancer, small-cell lung cancer or neuroendocrine tumor) for which a standard of care Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is planned
* Planned pre-procedural IV antibiotic. The choice of antibiotic type is up to the treatment physician(s)
* Able to safely hold all oral medications on the day of surgery and the day after to ensure the absorption of such drugs is not affected due to charcoal ingestion the night before surgery
* 18 years of age or older
* Able to provide written consent prior to any research related activities
Exclusion Criteria:
* Current pregnancy or breastfeeding (SOC pre-TEMLA testing/assessment)
* Any current diagnosed disease with known involvement of the gastrointestinal tract
* Known allergy to oral activated charcoal
* CTCAE v 5 Dysphagia Grade 2 (symptomatic and altered eating/swallowing) or greater
* Known risk of aspiration based on history or current complaints
* Gastrointestinal procedures within 2 weeks before or (planned) after TEMLA
* Systemic antibiotic use within 8 weeks before planned TEMLA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04928950
Study Brief:
Protocol Section:
NCT04928950