Ovarian CancerGYNO-MIRNCT03776630
Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
A study testing Blood sample in people with Ovarian Cancer and Endometrial Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This trial is a non-randomized, open label and multicenter study. It aims to : for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2019to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- For all patients (EC, OC, Control)
- Written informed consent;
- Age ≥ 18 years old;
- Patient affiliated to social security.
- EC patients
- Histologically proven EC ;
Show all 13Show fewer
- Type 1 and 2 EC;
- FIGO stage I or II or III EC requiring first intention surgical staging.
- OC patients
- Histologically proven OC or strong suspicion of OC on clinical arguments (abdomino-pelvian mass detected by palpation or echography and/or ascitis and/or elevated CA125);
- Epithelial OC: any histological subtype;
- FIGO stage I to IV OC.
- Control patients - Any lesion which is supposed to be benign and requires surgery. -
Who cannot join
- For all patients (OC, EC, Control)
- Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- Deprived of liberty or under legal protection measure;
- Ongoing pregnancy;
- Control patients:
- Previous history of cancer.
Show all 11Show fewer
- EC patients
- FIGO stage IV at preoperative imaging techniques.
- Previous history of cancer. OC patients
- Non epithelial cancer.
- Previous history of cancer - except for patients who developed breast cancer at least 5 years or more before ovarian cancer.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie et oncologie gynécologique et mammaire
Paris, Île-de-France Region, 75013
About this study
This trial is a non-randomized, open label and multicenter study.
It aims to :
for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
Read the detailed description
MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or suppressors. There is now ample evidence that circulating miRs can be used as biomarkers. This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the deadliest and most frequent gynecologic malignancies.
The main challenge for physicians managing women with early-stage EC is when to opt for lymphadenectomy. Tools that are currently used are not accurate enough to identify women with increased risk of nodal metastases. Ballester's team recently found a relationship between the high expression of a set of 5 miRs in the primary tumor and nodal status.
OC is the leading cause of death from gynecological cancer. The prognosis depends on the response of the residual tumor mass to adjuvant chemotherapy. Currently, this response remains largely unpredictable and even difficult to monitor with CA125 measurements and current imaging techniques. Busson's team recently showed that the variation of plasma miR200b during primary treatment is predictive of progression-free survival (PFS).
The study involves 3 populations of participants :
- Patients with EC
- Patients with OC
- Patients undergoing surgery for benign pelvic lesions (control population)
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Being tested
- Blood sample
- Keywords
- Ovarian cancer, endometrial cancer, miR, diagnostic
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Two blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population.
For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Patients undergoing surgery for benign pelvic lesions Receives: Other: Blood sample |
| Ovarian Cancer | Other | Not described Receives: Other: Blood sample |
| Endometrial Cancer | Other | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.
Measured: 2 months
For OC: PFS or death for any cause at 24 months.
To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
Measured: 24 months
Secondary outcomes (5)
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.
Histopathological characteristics of the tumor in the context of EC: grade
Measured: 2 months
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)
Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid
Measured: 2 months
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC
PFS for both EC and OC
Measured: 60 months
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC
OS (defined as the time from the start of the treatment to death) for both EC and OC
Measured: 60 months
Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.
it aims to validate multiplexed homogenous miR detection based on RCA-FRET compared to conventional qRT-PCR in plasma samples. It also aims to search for novel plasma miRs potentially informative on lymph node involvement (EC) or PFS (OC) by high throughput sequencing (RNA seq).
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start23 May 2019
- Primary completion18 May 2024
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffroy CANLORBE, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776630
- Sponsor's protocol ID
- K160922J
- Other IDs
- 2018-A00018-47
- Acronym
- GYNO-MIR
- Status last verified
- Aug 2025
- First submitted
- 24 Sep 2018
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors
- ClinicalTrials.gov ID
- NCT03776630
- Acronym / sponsor ID
- GYNO-MIR / K160922J
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Keywords
- Ovarian cancer, endometrial cancer, miR, diagnostic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 May 2019 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 17 Dec 2018 (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.
This trial is a non-randomized, open label and multicenter study.
It aims to :
for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
Detailed description
MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or suppressors. There is now ample evidence that circulating miRs can be used as biomarkers. This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the deadliest and most frequent gynecologic malignancies.
The main challenge for physicians managing women with early-stage EC is when to opt for lymphadenectomy. Tools that are currently used are not accurate enough to identify women with increased risk of nodal metastases. Ballester's team recently found a relationship between the high expression of a set of 5 miRs in the primary tumor and nodal status.
OC is the leading cause of death from gynecological cancer. The prognosis depends on the response of the residual tumor mass to adjuvant chemotherapy. Currently, this response remains largely unpredictable and even difficult to monitor with CA125 measurements and current imaging techniques. Busson's team recently showed that the variation of plasma miR200b during primary treatment is predictive of progression-free survival (PFS).
The study involves 3 populations of participants :
- Patients with EC
- Patients with OC
- Patients undergoing surgery for benign pelvic lesions (control population)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Blood samplePatients undergoing surgery for benign pelvic lesions |
| Ovarian Cancer | Other | Other: Blood sample |
| Endometrial Cancer | Other | Other: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For all patients (EC, OC, Control)
- Written informed consent;
- Age ≥ 18 years old;
- Patient affiliated to social security.
- EC patients
Key exclusion criteria (11 listed)
- For all patients (OC, EC, Control)
- Unable or unwilling to comply with the protocol requirements and/or unwilling to sign an informed consent form.
- Deprived of liberty or under legal protection measure;
- Ongoing pregnancy;
- Previous history of 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 sampleTwo blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population. For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample. | Other | Control, Endometrial Cancer, Ovarian Cancer |
Primary outcome
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
Time frame: 2 months
To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.
For OC: PFS or death for any cause at 24 months.
Time frame: 24 months
To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
5 secondary outcomes
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.
Time frame: 2 months
It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)
Time frame: 2 months
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC
Time frame: 60 months
It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC
Time frame: 60 months
Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
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
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
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.
Geoffroy CANLORBE, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Ovarian Cancer and Endometrial Cancer, run by Assistance Publique - Hôpitaux de Paris 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 13 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique). (time frame: 2 months). The study lists 2 primary outcomes in all. 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 12 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.