Circulating Tumor DNANCT04456972
Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.
A study testing One arm only in people with Circulating Tumor DNA and Endometrial Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Circulating Tumor DNA, Endometrial Cancer
- What is being tested?
- One arm only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 8 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
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).
Read more
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.
- Conditions
- Circulating Tumor DNA, Endometrial Cancer
- Being tested
- One arm only
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One arm onlyDiagnostic test
Samples of plasma to analyze ctDNA
| Study group | Role | What they receive |
|---|---|---|
| One arm only | Experimental | Not described Receives: Diagnostic Test: One arm only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
Measured: 15 days
Secondary outcomes (2)
Analysis of the association of molecular anomalies on cDNA with clinical histological data.
Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
Measured: 15 days
Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.
Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start19 Jun 2020
- Primary completion8 Jan 2022
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNAStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Mrs EVRARD, PHD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456972
- Sponsor's protocol ID
- ENDOCIRC
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time. If we failed to obtain results we perhaps send plasma in other laboratory
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT04456972
- Acronym / sponsor ID
- ENDOCIRC
- Conditions
- Circulating Tumor DNA, Endometrial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 8 Jan 2022 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm only | Experimental | Diagnostic Test: One arm only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One arm onlySamples of plasma to analyze ctDNA | Diagnostic test | One arm only |
Primary outcome
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
2 secondary outcomes
Analysis of the association of molecular anomalies on cDNA with clinical histological data.
Time frame: 15 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No. Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time. If we failed to obtain results we perhaps send plasma in other laboratory
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Mrs EVRARD, PHD principal investigator
CHU Poitiers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One arm only in people with Circulating Tumor DNA and Endometrial Cancer, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.