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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT04824950
Eligibility Criteria:
Inclusion Criteria:
* Patient over 18 years of age,
* Suffering from a diffuse primary B lymphoma of the mediastinum, newly diagnosed locally on a biopsy with anatomopathological analysis according to the recommendations of the WHO 2016 classification of hematological malignancies,
* All stages (I-IV)
* All IPI scores (0-5)
* With mediastinal involvement,
* Untreated (apart from emergency corticosteroid therapy less than 2mg/kg/day for 7 days),
* Treatment with R-CHOP-14 or R-ACVBP with PET-CT guided strategy (delta SUVmax) to be initiated,
* Tumor fixation above liver background on pre-treatment FDG PET/CT/CT (Deauville score ≥4),
* Having signed the informed consent prior to any study procedure
* Affiliated or beneficiary of a social protection plan.
Exclusion Criteria:
* Patient who has already started chemotherapy treatment,
* Contraindication to FDG PET-CT,
* No mediastinal involvement,
* Positive HIV serology,
* Positive hepatitis B or C serology with positive viral load,
* Protected adult (under guardianship or curatorship),
* Pregnant or breastfeeding women,
* Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04824950
Study Brief:
Protocol Section:
NCT04824950