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出境医 / 临床实验 / Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery. (E-CTC)
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery. (E-CTC)
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Endometrial Cancer | Procedure: blood samples | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | women with endometrial cancer |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| Official Title: | Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery |
| Actual Study Start Date : | July 16, 2019 |
| Estimated Primary Completion Date : | July 16, 2021 |
| Estimated Study Completion Date : | March 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| women with endometrial cancer |
Procedure: blood samples
3 samples: One before surgery on the arm vein (peripheral) Two during the surgery, on two different venipuncture site :
|
Outcome Measures
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- Quantitative assessment [ Time Frame: Before surgery and during surgery ]Number of CTC detected from each sampling
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with endometrial cancer
- Being affiliated or benefiting from a French social security system
Exclusion Criteria:
- Patients with an other cancer
Contacts and Locations
Contacts
| Contact: Gauthier RATHAT, PHD | 0467336532 | g-rathat@chu-montpellier.fr | |
| Contact: Sarah FRANCINI, resident | s-francini@chu-montpellier.fr |
Locations
| France | |
| Montpellier University Hospital | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Gauthier RATHAT, MD 0467336532 g-rathat@chu-montpellier.fr | |
| Principal Investigator: Gauthier RATHAT, MD | |
| Sub-Investigator: Lucie REBEL, MD | |
| CHU de Nîmes | Recruiting |
| Nîmes, France, 30029 | |
| Contact: Renaud DE TAYRAC, MD PhD renaud.detayrac@chu-nimes.fr | |
| Principal Investigator: Renaud DE TAYRAC, MD PhD | |
| Sub-Investigator: Catherine FERRER, MD | |
| Sub-Investigator: Florent MASIA, MD | |
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
| Study Director: | Gauthier RATHAT, PHD | University of Montpellier |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 15, 2019 | ||||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||||
| Last Update Posted Date | December 17, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 16, 2019 | ||||||||
| Estimated Primary Completion Date | July 16, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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).
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
Quantitative assessment [ Time Frame: Before surgery and during surgery ] Number of CTC detected from each sampling
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery. | ||||||||
| Official Title ICMJE | Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery | ||||||||
| Brief 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. 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: women with endometrial cancer Masking: None (Open Label)Primary Purpose: Screening |
||||||||
| Condition ICMJE | Endometrial Cancer | ||||||||
| Intervention ICMJE | Procedure: blood samples
3 samples: One before surgery on the arm vein (peripheral) Two during the surgery, on two different venipuncture site :
|
||||||||
| Study Arms ICMJE | women with endometrial cancer
Intervention: Procedure: blood samples
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
10 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 2022 | ||||||||
| Estimated Primary Completion Date | July 16, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04021459 | ||||||||
| Other Study ID Numbers ICMJE | RECHMPL19_0178 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University Hospital, Montpellier | ||||||||
| Study Sponsor ICMJE | University Hospital, Montpellier | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | University Hospital, Montpellier | ||||||||
| Verification Date | December 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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