Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
Primary Purpose
Breast Cancer, Digestive Cancer, Gynecologic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
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
Sites / Locations
- CHU POitiersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One arm only
Arm Description
Only one arm with blood samples
Outcomes
Primary Outcome Measures
To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.
Correlation between ctDNA and overall survival
Secondary Outcome Measures
Evaluate the diagnostic value of ctDNA and exosomes
ct DNA and exosomes analyses can be new tools for cancer diagnosis
Evaluate the prognostic impact of exosomes and their composition
There are many kind of exomossomes with few different composition and different roles
Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments
Correkation between ctDNA/exosomes and progression free survival
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
Full Information
NCT ID
NCT04530890
First Posted
August 11, 2020
Last Updated
February 7, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04530890
Brief Title
Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
Official Title
Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
September 2030 (Anticipated)
Study Completion Date
September 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Digestive Cancer, Gynecologic Cancer, Circulating Tumor DNA, Exosomes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One arm only
Arm Type
Experimental
Arm Description
Only one arm with blood samples
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples
Intervention Description
Only blood samples at different times of treatment
Primary Outcome Measure Information:
Title
To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.
Description
Correlation between ctDNA and overall survival
Time Frame
Through study completion, an average of 12 months
Secondary Outcome Measure Information:
Title
Evaluate the diagnostic value of ctDNA and exosomes
Description
ct DNA and exosomes analyses can be new tools for cancer diagnosis
Time Frame
Through study completion, an average of 12 months
Title
Evaluate the prognostic impact of exosomes and their composition
Description
There are many kind of exomossomes with few different composition and different roles
Time Frame
Through study completion, an average of 12 months
Title
Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments
Description
Correkation between ctDNA/exosomes and progression free survival
Time Frame
Through study completion, an average of 12 months
Title
Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes
Description
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 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille EVRARD, PHD
Phone
+33549444279
Email
camille.evrard@chu-poitiers.fr
Facility Information:
Facility Name
CHU POitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille EVRARD, Dr
12. IPD Sharing Statement
Learn more about this trial
Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
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