11th International Symposium on Circulating Nucleic Acids in Plasma and Serum (CNAPS)

Clinical studies on the predictive information, minimal residual disease and follow up of colorectal cancer patients by circulating cell-free DNA analysis

Brice Pastor 1,2,3,4 Jean-Daniel Abraham 1,2,3,4 Romain Meddeb 1,2,3,4 Muriel Mathonnet 5 Federica Di Nicolantonio 6 Ramon Salazar 7 Elena Elez 8 Thibault Mazard 4 Marc Ychou 4 Alain Roger Thierry 1,2,3,4
1IRCM, Institut de recherche en Cancérologie de Montpellier, Montpellier, Herault, France
2INSERM, U1194, Montpellier, Herault, France
3UM, Université de Montpellier, Montpellier, Herault, France
4ICM, Institut regional du cancer de Montpellier, Montpellier, Herault, France
5Département de chirurgie digestive, Centre Hospitalier Universitaire, Limoges, Limousin, France
6Department of Oncology, Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia (FPO), Candiolo, Piemonte, Italy
7Medical Oncology Service and Colorectal Cancer Unit, Catalan Institute of Oncology, Barcelona, Catalunya, Spain
8Department Servicio de Oncología Médica, Vall d'Hebron University Hospital, Barcelona, catalunya, Spain

Circulating cell-free DNA (cfDNA) analysis constitutes a hopeful approach to provide a non-invasive molecular test for cancer patients. Analyzing this new biological source may have important implications in a shift towards personalized medicine for diagnosing and/or monitoring malignancies. We developed a novel multi-marker assay called IntPlex® that has been clinically validated for detecting RAS/BRAF mutations in the blood of mCRC patients and can be adapted to all mutations. In order to validate the use of IntPlex® method for cfDNA analysis as a cancer biomarker of prognosis, theranostic, detection of the minimal residual disease (MRD) and the outcome of relapse, three independent studies are conducted by our group to address these specific issues.

  1. DNAcir study (NCT02813928) is an open, prospective and multicenter study. The primary endpoint is to evaluate the diagnostic and prognostic value of cfDNA analysis at the inclusion for the early detection of recurrences within the 3 years of follow up in patients curatively treated for stage II-III CRC.
  2. THRuST study primary objective is to determine, in stage III MSS CRC patients, the proof of concept of cfDNA detection for the identification of post-surgery recurrence. The cfDNA will be longitudinally analyzed for the presence of a personalized molecular signature by NGS analysis.
  3. PANIRINOX study (NCT02980510) is the first interventional multicenter open-label randomized phase II study with selection of RAS/BRAF WT mCRC patients according to analysis of ctDNA by Intplex method. Primary objective is the evaluation of complete response rate on treatments. Secondary objectives are to assess the OS, PFS and the diagnostic performance of cfDNA analysis as compared to the tumor-tissue analysis.

Those studies will contribute to demonstrate the clinical usefulness of cfDNA during all the patients’ management care, as well as Intplex® method. Dynamic follow up by cfDNA analysis might help clinicians to better and earlier adjust treatment and to improve surveillance of cancer patients.









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