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Recruiting Not applicable

Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer

NCT04530890 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-03-08
Last updated
2025-12-24

Condition(s) studied

Breast CancerDigestive CancerGynecologic CancerCirculating Tumor DNAExosomes

Investigational drug(s) / intervention(s)

Blood samples

Blood samples: Only blood samples at different times of treatment

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers. — Through study completion, an average of 12 months
    Correlation between ctDNA and overall survival

Trial sites (1)

FacilityCityRegionStatus
CHU POitiers Poitiers France Recruiting
Official registry record

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.

View NCT04530890 on ClinicalTrials.gov ↗ ← All trials in France