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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT04192695
Eligibility Criteria:
Inclusion Criteria:
Patients with esophageal squamous cell cancer (ESCC):
* Patients ≥18 years of with adequate performance status for endoscopy
* Newly diagnosed ESCC suitable for endoscopic or oncological treatment (Rth/Chth)
* Patients currently undergoing oncological treatment (Rth/Chth)
* Consent to provide tissue samples for the study
* Dysphagia grade ≤2 (able to swallow mixed foods and tablets)
Patients at high risk for ESCC:
* Patients ≥18 years of age with adequate performance status for endoscopy
* Prior definitive treatment for head and neck cancer (cancer of the oral cavity, hypopharyngeal cancer, laryngeal carcinoma) and at least 12 months post-therapy (both Rth, Chth, and combination treatment)
* Prior definitive endoscopic treatment for early ESCC in the past (at least 6 months since completion)
* Consent to provide tissue samples for the study
* Dysphagia grade ≤2
Exclusion Criteria (for both groups of patients):
* Patients currently on anticoagulant treatment (warfarin, acenocoumarol) with no possibility of stopping / modification
* Dysphagia grade ≥3 (able to swallow only liquid foods)
* History of myocardial infarction or other cardiovascular event within 6 months of enrolment
* Neurological diseases associated with impaired swallowing
* Patients in long-term care or institutional care (physical, psycho-social disorders, intellectual disability).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04192695
Study Brief:
Protocol Section:
NCT04192695