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NCT Number: NCT04456972

Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.

After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).

This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.

The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.

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Key information

Conditions

Circulating Tumor DNA Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers, PRC

Poitiers, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically proven endometrial adenocarcinoma type I or type II.
  • With recent abdomino-pelvic imaging, less than 3 months old.
  • Tumor tissue sufficiently exploitable for research (> 20% of tumor cells)
  • Informed consent signed by the patient after clear and fair information about the study.
  • Free patient, without tutorship, curatorship or subordination.
  • Patient benefiting from a Social Security scheme or benefiting from it through a third person.
  • Patient not opposed to participating in the study.

Exclusion criteria

  • Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
  • Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
  • Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
  • Pregnant and / or lactating women

Treatment and study plan

One arm only

Diagnostic Test

Samples of plasma to analyze ctDNA

Primary outcomes

  1. The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.

    Time frame: 15 days

    Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment

Secondary outcomes

  1. Analysis of the association of molecular anomalies on cDNA with clinical histological data.

    Time frame: 15 days

    Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.

  2. Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.

    Time frame: 3 months

    Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Jan 4, 2023

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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