Evaluating blood tests for treatment response in rectal cancer
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
This study is testing whether blood tests can help doctors see how well treatment is working for patients with rectal cancer so they can better plan their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04852653 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the assessment of treatment response in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy by analyzing extracellular vesicles obtained from liquid biopsies. It will collect blood samples at various stages of treatment to detect tumor-derived vesicles, which may serve as molecular markers for identifying patients who respond well to therapy. The goal is to enhance the accuracy of response evaluation, potentially allowing for organ preservation strategies in good responders. By comparing the presence of these vesicles before, during, and after treatment, the study seeks to provide a more reliable method for patient management.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically proven adenocarcinoma of the rectum, specifically those with stage T3T4 or T2 low rectal cancer who are operable and likely to receive neoadjuvant treatment.
Not a fit: Patients with metastatic rectal cancer or those who have previously undergone pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate treatment assessments and better organ preservation strategies for rectal cancer patients.
How similar studies have performed: While the use of liquid biopsies in cancer assessment is an emerging field, this specific approach focusing on extracellular vesicles in rectal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adenocarcinoma of rectum histologically proven * Location ≤ 10 cm from the anal margin * Stage T3T4, or T2 if low rectal cancer * With indication of radiochemotherapy alone or chemotherapy followed by chemoradiotherapy prior to total mesorectal surgery or transanal surgery * No metastasis * Operable patient * Patient ≥ 18 years old * Patient likely to receive radiation therapy and chemotherapy. * No history of pelvic radiotherapy for any reason * No history of chemotherapy unless it was more than 10 years ago * Effective contraception for patients of childbearing age: male and non-menopausal women must agree to use two medically validated methods of contraception (one for the patient and the other for the partner) during treatment and less up to 6 months for men and 4 months for women after last treatment * Patient information and obtaining free, informed and written consent, signed by the patient and his investigator. * Affiliate subject or beneficiary of a social security scheme of a member country of the European Community (article L1121-11 of the Code of Public Health) Exclusion Criteria: * Tumor of the upper rectum (\> 10 cm from the anal margin) * Metastatic disease . T1 stage tumor * History of pelvic radiotherapy and chemotherapy * Contraindication to chemotherapy and / or radiotherapy . Insufficient tumoral sample on initial rectal biopsy for performing molecular analysis of tumor by NGS. * Other concomitant cancer or history of cancer other than treated in situ cervix cancer or basal cell or squamous cell carcinoma * Pregnant woman, likely to be pregnant or breastfeeding * Symptomatic cardiac and / or coronary insufficiency * Severe renal impairment (creatinine clearance less than 30ml / min) * Full or partial deficiency in dihydropyrimidine dehydrogenase (DPD) (uracilemia ≥ 16 ng / ml) * Peripheral neuropathy\> grade 1 * Treatment with St. John's Wort * Treatment with yellow fever vaccine * Treatment with prophylactic phenytoin * Treatment with sorivudine or its chemically analogues related, such as brivudine * Active infection or other serious underlying disease likely to prevent the patient from receiving treatment * Persons deprived of their liberty, or under measure of judicial protection (curatorship or guardianship) or incapable of giving their consent * Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons.
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Samuel AMINTAS
- Email: samuel.amintas@chu-bordeaux.fr
- Phone: +33 (0)5 57 62 32 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.