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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02832102
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma
* Clinical stage III and IV
* Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy
* Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections)
* Availability of baseline diffusion-weighted imaging (DWI) - Magnetic Resonance Imaging (MRI) acquisition (non-TRACE ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition.
* MRI images, T1 and T2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or CT scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast
* Male or female ≥ 18 years old
Exclusion Criteria:
* Any previous haed and neck cancer.
* Patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
* Any previous malignancy that was treated with surgery and or radiation of the head and neck region.
* Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02832102
Study Brief:
Protocol Section:
NCT02832102