Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Digestive Cancer, Gynecologic Cancer, Circulating Tumor DNA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Diagnostic test Blood samples
Only blood samples at different times of treatment
Primary outcome measures
- To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers. [Time frame: Through study completion, an average of 12 months]
Secondary outcome measures (4)
- Evaluate the diagnostic value of ctDNA and exosomes [Time frame: Through study completion, an average of 12 months]
- Evaluate the prognostic impact of exosomes and their composition [Time frame: Through study completion, an average of 12 months]
- Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments [Time frame: Through study completion, an average of 12 months]
- Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes [Time frame: Through study completion, an average of 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CHU POitiers — Poitiers
Identifiers
NCT: NCT04530890 · ADIGYN