Clinical trial · Observational
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
NCT04852653CI-TRIAL-00092790RECC-EVactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and leads to frequent false positive and negative results. Molecular markers reflecting the initial and post-nCRT status of the tumor would be ideal to select patients eligible for organ preservation. This project will test the detection of tumor extracellular vesicles (EVs) in liquid biopsy as a reliable marker for the identification of poor versus good responders to nCRT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liquid Biopsy | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supplementary blood samples collection during the normal follow up of the patients | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with adenocarcinoma of rectum histologically proven
- interventionNames
- Procedure: Supplementary blood samples collection during the normal follow up of the patients
Primary outcomes (1)
- measure
- Positivity of the liquid biopsy
- timeFrame
- 6 months
- description
- Presence of onco-exosomes and / or exoDNA according to the response to the neoadjuvant treatment by chemotherapy alone or followed by radiochemotherapy of rectal cancer
Secondary outcomes (2)
- measure
- Prediction of the response of rectal cancer to neoadjuvant treatment
- timeFrame
- 6 months
- description
- To evaluate whether the kinetics of detection of oncoexosomes and exoDNA is a predictor of the response of rectal cancer to neoadjuvant treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.