RecruitingNot ApplicableNCT04530890

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


Sponsor

Poitiers University Hospital

Enrollment

1,000 participants

Start Date

Mar 8, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether measuring fragments of tumor DNA circulating in the blood (liquid biopsy) can help doctors monitor and guide treatment in patients with digestive or breast/gynecological cancers. **You may be eligible if...** - You have a confirmed or suspected digestive cancer (such as colorectal, stomach, or liver) or a breast or gynecological cancer - You are scheduled to receive chemotherapy or immunotherapy - You are an adult (18 or older) **You may NOT be eligible if...** - You are unable to understand or sign the consent form due to language or psychological barriers - You have had a different cancer within the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood samples

Only blood samples at different times of treatment


Locations(1)

CHU POitiers

Poitiers, France

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NCT04530890


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