Liquid Biopsies and IMAging for Improved Cancer Care

NCT04224779 | Active Not Recruiting

• 1 other identifier: PROICM 2019-04 LIM
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  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).

  Through study completion, an average of 3.5 years

Secondary Outcomes (12)

• Area under the Receiver Operating Characteristic (ROC) curve of the total cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2)

  Through study completion, an average of 3.5 years

• Area under the Receiver Operating Characteristic (ROC) curve of the mutant cfDNA percent change between the baseline sample (T1) and the first sample during the neo-adjuvant treatment (T2) [resp the sample at the end of neo-adjuvant treatment (T3)]

  Through study completion, an average of 3.5 years

• Number of Circulating tumor cells (CTCs) found in blood

  Through study completion, an average of 3.5 years

• Tumoral response assessed by Magnetic resonance Imaging (MRI)

  Through study completion, an average of 3.5 years

• Response to treatment by using a radiomics algorythm

  Through study completion, an average of 3.5 years

Study Arms (1)

Tumors and blood collection

EXPERIMENTAL

For all the patients included in the study : * Blood samples will be collected at different times T1 (Baseline), T2 (1 or 2 weeks after the beginning of the treatment), T3 (3 or 4 weeks before the surgery) and T4 (1 month after the surgery). * Tumors biopsy will be collected for some patients who will benefit from an initial biopsy in the course of his management care in our Institute (before the surgery). In parallel to this biological collection, imaging and clinical data will be entered into a database treatment.

Biological: Biological collection

Interventions

Biological collection BIOLOGICAL

The biological collection will include samples of blood samples collected at different times but also tumoral biopsy before the surgery.

Tumors and blood collection

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Histologically-confirmed diagnosis of adenocarcinoma of the rectum
• Distal part of the tumour within 2 to 12 cm of the anal margin
• Candidate for Neoadjuvant chemotherapy (NAT)
• Measurable disease (using the Recist criteria v1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• General condition considered suitable for radical pelvic surgery
• Adequate bone marrow, hepatic and renal function
• Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules
• Patient being able to follow all the treatment as well as the follow-ups planned in this study

You may not qualify if:

• Patient with metastatic disease
• Symptomatic cardiac or coronary insufficiency
• Severe renal insufficiency
• Progressive active infection or any other severe medical condition
• Other cancer treated within the last 5 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma
• Pregnant or breast-feeding woman
• Unaffiliated patient to French Social Protection System
• Persons deprived of liberty or under guardianship or incapable of giving consent
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Insitut Régional du Cancer de Montpellier

Montpellier, Hérault, 34298, 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 Officials

• Philippe Rouanet, MD

  Institut Régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 18, 2021
• Primary Completion: May 31, 2022
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)