Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Blood samples
Diagnostic testOnly blood samples at different times of treatment
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: One arm onlyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.
Correlation between ctDNA and overall survival
Time frame
Through study completion, an average of 12 monthsSecondary outcomes
1
Evaluate the diagnostic value of ctDNA and exosomes
ct DNA and exosomes analyses can be new tools for cancer diagnosis
Time frame
Through study completion, an average of 12 months2
Evaluate the prognostic impact of exosomes and their composition
There are many kind of exomossomes with few different composition and different roles
Time frame
Through study completion, an average of 12 months3
Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments
Correkation between ctDNA/exosomes and progression free survival
Time frame
Through study completion, an average of 12 months4
Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes
With new technics of biology molecular, we are going to try to detect molecular alterations in ctDNA /exosomes
Time frame
Through study completion, an average of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov