NCT04530890 Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
| NCT ID | NCT04530890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2032-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2021-03-08 with a primary completion date of 2032-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Circulating tumor DNA (ctDNA) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. It is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. These advances in ctDNA have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctDNA requires very sensitive techniques such as Next Generation Sequencing (NGS). CtDNA overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. All of these applications make circulating DNA an increasingly essential tool in the management of cancer patients. The studies are currently in most cases on small numbers and are retrospective. In addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . Exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. They are very informative since they transport tumor genetic material in the form of DNA, mRNA and miRNA, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and Heats shock proteins ( HSP). The aim of the ADIGYN study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctDNA and exosomes in digestive and gynecological / breast cancers. From the circulating DNA, we characterize the ActDNA on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. To assess resistance to oncological treatments, ctDNA will be analyzed at the start of treatment, during treatment, during progression and / or relapse and also during monitoring or treatment break
Eligibility Criteria
Inclusion Criteria: * Digestive or gynecological / breast cancer proven or suspected, requiring oncological treatment (chemotherapy or immunotherapy) * Major patient * Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party * Information note and collection of non-opposition after clear and fair information about the study Exclusion Criteria: * Linguistic or psychological refusal or inability to understand and / or sign the information and no-objection note * History of a cancer other than that allowing inclusion in the 5 years preceding inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04530890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04530890 currently recruiting?
Yes, NCT04530890 is actively recruiting participants. Contact the research team at camille.evrard@chu-poitiers.fr for enrollment information.
Where is the NCT04530890 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT04530890 clinical trial?
NCT04530890 is sponsored by Poitiers University Hospital. The trial plans to enroll 1,000 participants.
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