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

NCT04530890 | Recruiting

• 1 other identifier: ADIGYN
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Exosomes; Breast Cancer; Digestive Cancer; Gynecologic Cancer; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.

  Correlation between ctDNA and overall survival

  Through study completion, an average of 12 months

Secondary Outcomes (4)

• Evaluate the diagnostic value of ctDNA and exosomes

  Through study completion, an average of 12 months

• Evaluate the prognostic impact of exosomes and their composition

  Through study completion, an average of 12 months

• Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments

  Through study completion, an average of 12 months

• Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes

  Through study completion, an average of 12 months

Study Arms (1)

One arm only

EXPERIMENTAL

Only one arm with blood samples

Diagnostic Test: Blood samples

Interventions

Blood samples DIAGNOSTIC_TEST

Only blood samples at different times of treatment

One arm only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Linguistic or psychological refusal or inability to understand and / or sign the information and no-objection note

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU POitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Camille EVRARD, PHD

CONTACT

+33549444279; camille.evrard@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 28, 2020
• Study Start: March 8, 2021
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)