Biological collection: The biological collection will include samples of blood samples collected at different times but also tumoral biopsy before the surgery.
Study summary
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal cancer: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in Neoadjuvant chemotherapy (NAT) for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project's overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old
2. Histologically-confirmed diagnosis of adenocarcinoma of the rectum
3. Distal part of the tumour within 2 to 12 cm of the anal margin
4. Candidate for Neoadjuvant chemotherapy (NAT)
5. Measurable disease (using the Recist criteria v1.1)
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
7. General condition considered suitable for radical pelvic surgery
8. Adequate bone marrow, hepatic and renal function
9. Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules
10. Patient being able to follow all the treatment as well as the follow-ups planned in this study
Exclusion Criteria:
1. Patient with metastatic disease
2. Symptomatic cardiac or coronary insufficiency
3. Severe renal insufficiency
4. Progressive active infection or any other severe medical condition
5. Other cancer treated within the last 5 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma
6. Pregnant or breast-feeding woman
7. Unaffiliated patient to French Social Protection System
8. Persons deprived of liberty or under guardianship or incapable of giving consent
9. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
Primary outcome measure(s)
Area under the Receiver Operating Characteristic (ROC) curve of total cfDNA (defined as circulating cell-free DNA in plasma) percent change between the baseline sample (T1) and the sample at the end of the neo-adjuvant treatment (T3) — Through study completion, an average of 3.5 years This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response (defined as Grade 3 and 4 of Dworak definition) to neo-adjuvant treatment
Pathological response (at surgery) is defined as Dworak definition below:
* No regression (0),
* Predominantly tumour with significant fibrosis and/or vasculopathy (1),
* Predominantly fibrosis with scattered tumour cells (slightly recognizable histologically) (2),
* Only scattered tumour cells in the space of fibrosis with / without acellular mucin (3)
* No vital tumour cells detectable (4).
Trial sites (1)
Facility
City
Region
Status
Insitut Régional du Cancer de Montpellier
Montpellier
Hérault
More Institut du Cancer de Montpellier - Val d'Aurelle trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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