French Assessment of MRD by Liquid Biopsies in PDAC Patients (FRENCH.MRD.PDAC)

NCT06287749 | Recruiting

• 1 other identifier: RECHMPL23_0298
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice. Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence. Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after

1. 1.curative-intended surgery and
2. 2.adjuvant chemotherapy.

Conditions

Pancreatic Cancer Resectable; Pancreatic Ductal Adenocarcinoma; Minimal Residual Disease; Liquid Biopsy; ctDNA

Keywords

Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Resectable; Minimal Residual Disease; Liquid Biopsy; ctDNA

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-free survival (DFS)

  Disease-free survival was defined as the time between the date of the baseline blood sampling/inclusion and the date of the first event among or recurrence or death from any cause.

  3 years after the end of inclusion

Secondary Outcomes (8)

• Sensitivity (Se) of the ctDNA diagnostics

  3 years after the end of inclusion

• Specificity (Sp) of the ctDNA diagnostics

  3 years after the end of inclusion

• Positive predictive value of the ctDNA diagnostics

  3 years after the end of inclusion

• Negative predictive value of the ctDNA diagnostics

  3 years after the end of inclusion

• Are Under the Curve of the ctDNA diagnostics

  3 years atfer the end of inclusion

Study Arms (1)

Pancreatic Ductal Adenocarcinoma patients

Resectable PDAC patients

Biological: Blood sample/Liquid Biopsy

Interventions

Blood sample/Liquid Biopsy BIOLOGICAL

ctDNA analysis

Pancreatic Ductal Adenocarcinoma patients

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 resected PDAC

You may qualify if:

• Pancreatic ductal adenocarcinoma, according to the assessment of the MDT.
• Age 18 years or older.
• Scheduled for curative intent surgical resection.

You may not qualify if:

• Hereditary pancreatic cancer.
• Verified distant metastases.
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study.
• Other cancers (excluding prior pancreatic cancer or skin cancer other than melanoma) within 3 years from eligibility screening.
• Pregnant or nursing woman, or in childbearing age and not willing to use contraception
• Adult subject to a legal protection
• Not covered by Health insurance
• Patient unable to understand and sign written informed consent.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU de Montpellier

Montpellier, Hérault, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA analysis NGS on tumor specimens

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

Blood Specimen Collection; Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques

Study Officials

• Thomas BARDOL, M.D.

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Catherine ALIX-PANABIERES, Ph.D.

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Catherine ALIX-PANABIERES, Ph.D

CONTACT

+33411759931; c-panabieres@chu-montpellier.fr

Thomas BARDOL, M.D.

CONTACT

+33467339069; t-bardol@chu-montpellier.fr

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 1, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

FR (1)