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

• ClinicalTrials.gov Identifier: NCT04530890
• Recruitment Status: Recruiting
• First Posted: August 28, 2020
• Last Update Posted: February 15, 2022
• Sponsor: Poitiers University Hospital
• Information provided by (Responsible Party): Poitiers University Hospital

Study Description

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

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Digestive Cancer; Gynecologic Cancer; Circulating Tumor DNA; Exosomes	Diagnostic Test: Blood samples	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
• Actual Study Start Date: January 20, 2021
• Estimated Primary Completion Date: September 2030
• Estimated Study Completion Date: September 2030

Arms and Interventions

Arm	Intervention/treatment
Experimental: One arm only; Only one arm with blood samples	Diagnostic Test: Blood samples; Only blood samples at different times of treatment

Outcome Measures

Primary Outcome Measures :

1. To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers. [ Time Frame: Through study completion, an average of 12 months ]
   Correlation between ctDNA and overall survival

Secondary Outcome Measures :

1. Evaluate the diagnostic value of ctDNA and exosomes [ Time Frame: Through study completion, an average of 12 months ]
   ct DNA and exosomes analyses can be new tools for cancer diagnosis
2. Evaluate the prognostic impact of exosomes and their composition [ Time Frame: Through study completion, an average of 12 months ]
   There are many kind of exomossomes with few different composition and different roles
3. Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments [ Time Frame: Through study completion, an average of 12 months ]
   Correkation between ctDNA/exosomes and progression free survival
4. Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes [ Time Frame: Through study completion, an average of 12 months ]
   With new technics of biology molecular, we are going to try to detect molecular alterations in ctDNA /exosomes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Camille EVRARD, PHD; +33549444279; camille.evrard@chu-poitiers.fr

Locations

France

CHU POitiers; Recruiting

Poitiers, France

Contact: Camille EVRARD, Dr

Sponsors and Collaborators

Poitiers University Hospital

More Information

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT04530890
• Other Study ID Numbers: ADIGYN
• First Posted: August 28, 2020
• Last Update Posted: February 15, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases