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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530890
• Other study ID #: ADIGYN
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: September 2030

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: Camille EVRARD, PHD
• Phone: +33549444279
• Email: camille.evrard[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2030
• Est. primary completion date: September 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Circulating Tumor DNA
• Digestive Cancer
• Exosomes
• Gynecologic Cancer

Intervention

Diagnostic Test:
• Blood samples
Only blood samples at different times of treatment

Locations

Country	Name	City	State
France	CHU POitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the diagnostic value of ctDNA and exosomes	ct DNA and exosomes analyses can be new tools for cancer diagnosis	Through study completion, an average of 12 months
Secondary	Evaluate the prognostic impact of exosomes and their composition	There are many kind of exomossomes with few different composition and different roles	Through study completion, an average of 12 months
Secondary	Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments	Correkation between ctDNA/exosomes and progression free survival	Through study completion, an average of 12 months
Secondary	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	Through study completion, an average of 12 months