Rectal CancerRECC-EVNCT04852653
A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
An observational study of Rectal Cancer and Liquid Biopsy, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Liquid Biopsy
- What is being tested?
- Supplementary blood samples collection during the normal follow up of the patients
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2021to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adenocarcinoma of rectum histologically proven
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Neoadjuvant treatment (NT) followed by total mesorectum excision (TME) constitues the gold standard for locally advanced carcinoma of the low and middle rectum. When good clinical response to NT is obtain, strategies with organ preservation, including close surveillance without immediate surgery or transanal local excision, can spare patients with the highly morbid and functional cost of TME. Current assessment of good responders relies on the downstaging and/or downsizing of the tumor as evaluated by MRI imaging and clinical exam. This strategy is prone to errors in more than 1/3 cases. Better assessment of tumor response to NT would better select patients eligible for organ preservation strategies. This study will use the detection of tumor extracellular vesicles (EVs) in liquid biopsy to identify good response of rectum cancer to neoadjuvant treatment. Tumor EVs will be detected in the blood of the patients at different times of their regular management (before, during and after NT). Protein content or tumor DNA in EVs will be detected after tumor DNA sequencing in the primary biopsies. Response will be assessed according to tumor EV presence or absence in the blood. As EV quantification is possible, kinetics of their detection will help response assessment and patient follow-up.
- Conditions
- Rectal Cancer, Liquid Biopsy
- Being tested
- Supplementary blood samples collection during the normal follow up of the patients
- Keywords
- Liquid biopsy, Rectal cancer, Extracellular vesicles, Exosome, ExoDNA
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplementary blood samples collection during the normal follow up of the patientsProcedure or surgery
Supplementary blood samples collection during the normal follow up of the patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with adenocarcinoma of rectum histologically proven | Not described Receives: Procedure: Supplementary blood samples collection during the normal follow up of the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Prediction of the response of rectal cancer to neoadjuvant treatment
To evaluate whether the kinetics of detection of oncoexosomes and exoDNA is a predictor of the response of rectal cancer to neoadjuvant treatment
Measured: 6 months
Genetic profile of the primary tumor predictive of the response to nCRT
To evaluate whether the initial mutational profile of the tumor is a predictor of the response of rectal cancer to chemotherapy and radiochemotherapy neoadjuvant treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start21 Sep 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852653
- Sponsor's protocol ID
- CHUBX 2020/21
- Acronym
- RECC-EV
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04852653
- Acronym / sponsor ID
- RECC-EV / CHUBX 2020/21
- Conditions
- Rectal Cancer, Liquid Biopsy
- Keywords
- Liquid biopsy, Rectal cancer, Extracellular vesicles, Exosome, ExoDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neoadjuvant treatment (NT) followed by total mesorectum excision (TME) constitues the gold standard for locally advanced carcinoma of the low and middle rectum. When good clinical response to NT is obtain, strategies with organ preservation, including close surveillance without immediate surgery or transanal local excision, can spare patients with the highly morbid and functional cost of TME. Current assessment of good responders relies on the downstaging and/or downsizing of the tumor as evaluated by MRI imaging and clinical exam. This strategy is prone to errors in more than 1/3 cases. Better assessment of tumor response to NT would better select patients eligible for organ preservation strategies. This study will use the detection of tumor extracellular vesicles (EVs) in liquid biopsy to identify good response of rectum cancer to neoadjuvant treatment. Tumor EVs will be detected in the blood of the patients at different times of their regular management (before, during and after NT). Protein content or tumor DNA in EVs will be detected after tumor DNA sequencing in the primary biopsies. Response will be assessed according to tumor EV presence or absence in the blood. As EV quantification is possible, kinetics of their detection will help response assessment and patient follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with adenocarcinoma of rectum histologically proven | – | Procedure: Supplementary blood samples collection during the normal follow up of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adenocarcinoma of rectum histologically proven
Key inclusion criteria (13 listed)
- Adenocarcinoma of rectum histologically proven
- Location ≤ 10 cm from the anal margin
- No metastasis
- Operable patient
- Patient ≥ 18 years old
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplementary blood samples collection during the normal follow up of the patientsSupplementary blood samples collection during the normal follow up of the patients | Procedure or surgery | Patients with adenocarcinoma of rectum histologically proven |
Primary outcome
Positivity of the liquid biopsy
Time frame: 6 months
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
2 secondary outcomes
Prediction of the response of rectal cancer to neoadjuvant treatment
Time frame: 6 months
Genetic profile of the primary tumor predictive of the response to nCRT
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Liquid Biopsy, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity of the liquid biopsy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.