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NCT Number: NCT04530890

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Circulating Tumor DNA Digestive Cancer Digestive System Diseases Digestive System Neoplasms Exosomes Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU POitiers

Poitiers, France

Location status: Recruiting

Location contact

Camille EVRARD, Dr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood samples

Diagnostic Test

Only blood samples at different times of treatment

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Camille EVRARD, PHD

CONTACT

[email protected]

+33549444279

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2032
Study completion
2032
First posted
Aug 28, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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