A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer

NCT04852653 | Active Not Recruiting

• 1 other identifier: CHUBX 2020/21
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Rectal Cancer; Liquid Biopsy

Keywords

Liquid biopsy; Rectal cancer; Extracellular vesicles; Exosome; ExoDNA

Outcome Measures

Primary Outcomes (1)

• Positivity of the liquid biopsy

  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

  6 months

Secondary Outcomes (2)

• Prediction of the response of rectal cancer to neoadjuvant treatment

  6 months

• Genetic profile of the primary tumor predictive of the response to nCRT

  6 months

Study Arms (1)

Patients with adenocarcinoma of rectum histologically proven

Procedure: Supplementary blood samples collection during the normal follow up of the patients

Interventions

Supplementary blood samples collection during the normal follow up of the patients PROCEDURE

Supplementary blood samples collection during the normal follow up of the patients

Patients with adenocarcinoma of rectum histologically proven

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adenocarcinoma of rectum histologically proven

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: September 21, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)