anal carcinoma anal cancer
Conditions
Interventions
n.v.t.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Patients with anal SCC who will start treatment, including:Mitomycin C + Capecitabine + radiotherapy; or patients with recurrent or metastatic anal SCC who will start treatment with either chemotherapy (e.g. carboplatin/paclitaxel) or immunotherapy. Note, the ACTOR biopsy may also be combined with the standard of care biopsy to confirm the diagnosis of anal SCC, in that case patients may be included based on the clinical diagnosis preceding the pathological confirmation.Patient’s age 18 years or older, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.Decisional capacity to consent to research.
Exclusion criteria
Exclusion criteria: 1. Safely obtain biopsy: If a biopsy cannot be safely obtained as determined by either the surgeon or the radiologist and/or the treating physician, the patient will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the ability to function as predictive biomarker for the standard of care therapies the following clinical endpoints are defined: For the organoids the following endpoints will be evaluated: • organoid establishment rate, time to establishment, time to screening. • for in vitro drug/radiotherapy screening: Area Under the Curve (AUC), GR50, GRmax. To correlate organoid response to clinical outcomes in the patient, the following endpoints will be evaluated: Primary anal SCC: Complete clinical response on clinical examination and pelvic MRI (CCR) versus no CCR at 6-months follow-up. Pelvic MRI consists of anatomical T2 weighted sequences and functional diffu-sion weighted imaging sequences (DWI); CCR on MRI is defined as a hypointense scar tissue on T2 weighted imaging without diffusion restriction. Metastatic anal SCC: The primary endpoint will be best radiological response by RECIST 1.1 within 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary anal SCC: Secondary endpoints are progression-free and overall survival which will be defined as the time from start of treatment until documented progression or disease related death. Metastatic anal SCC: Secondary progression-free survival will be defined as the time from start of treatment until documented progression or disease related death. | — |
Countries
Netherlands
Contacts
Public ContactJ.M.L. Roodhart
Universitair Medisch Centrum Utrecht
Outcome results
None listed