Endometrial CancerE-CTCNCT04021459
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.
A study testing blood samples in people with Endometrial Cancer, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Sep 2019to 16 Sep 2021
- 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
- Patients with endometrial cancer
- Being affiliated or benefiting from a French social security system
Who cannot join
- Patients with an other cancer
Trial locations and contacts
2 sites in 1 country.
France2 sites
Montpellier University Hospital
Montpellier, 34295
CHU de Nîmes
Nîmes, 30029
About this study
Official title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery
The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.
Read the detailed description
The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.
The main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).
- Conditions
- Endometrial Cancer
- Being tested
- blood samples
- Keywords
- endometrial cancer, circulating tumor cells, laparoscopy
- Medical subject headings
- Endometrial Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesProcedure or surgery
3 samples: One before surgery on the arm vein (peripheral)
Two during the surgery, on two different venipuncture site :
- One on the arm vein (peripheral)
- One on ovarian vein (close to the tumor) All samples will be tested by the CellSearch method.
| Study group | Role | What they receive |
|---|---|---|
| women with endometrial cancer | Other | Not described Receives: Procedure: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment
Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).
Measured: During surgery (at the ligature of the ovarian ligament)
Secondary outcomes (1)
Quantitative assessment
Number of CTC detected from each sampling
Measured: Before surgery and during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Sep 2019
- Primary completion15 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- women with endometrial cancer
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gauthier RATHAT, PHD, Study director, University of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021459
- Sponsor's protocol ID
- RECHMPL19_0178
- Acronym
- E-CTC
- Status last verified
- Sep 2021
- First submitted
- 15 Jul 2019
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Francini S, Duraes M, Rathat G, Macioce V, Mollevi C, Pages L, Ferrer C, Cayrefourcq L, Alix-Panabieres C. Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study. Biomolecules. 2023 Feb 24;13(3):428. doi: 10.3390/biom13030428.
PubMed 36979364
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery
- ClinicalTrials.gov ID
- NCT04021459
- Acronym / sponsor ID
- E-CTC / RECHMPL19_0178
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, circulating tumor cells, laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 16 Jul 2019 (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 purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.
Detailed description
The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.
The main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- women with endometrial cancer
| Arm | Type | Receives |
|---|---|---|
| women with endometrial cancer | Other | Procedure: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with endometrial cancer
- Being affiliated or benefiting from a French social security system
Key exclusion criteria (1 listed)
- Patients with an other cancer
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 |
|---|---|---|
| blood samples3 samples: One before surgery on the arm vein (peripheral) Two during the surgery, on two different venipuncture site : * One on the arm vein (peripheral) * One on ovarian vein (close to the tumor) All samples will be tested by the CellSearch method. | Procedure or surgery | women with endometrial cancer |
Primary outcome
Qualitative assessment
Time frame: During surgery (at the ligature of the ovarian ligament)
Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).
1 secondary outcome
Quantitative assessment
Time frame: Before surgery and during surgery
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 3 Oct 2023.
- Results publication: PubMed 36979364Francini S, Duraes M, Rathat G, Macioce V, Mollevi C, Pages L, Ferrer C, Cayrefourcq L, Alix-Panabieres C. Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study. Biomolecules. 2023 Feb 24;13(3):428. doi: 10.3390/biom13030428.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Gauthier RATHAT, PHD study director
University of Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Endometrial Cancer, run by University Hospital, Montpellier at 2 sites 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 2 inclusion and 1 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Qualitative assessment (time frame: During surgery (at the ligature of the ovarian ligament)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021459, which also lists 1 linked publication.
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 3 Oct 2023.