Ovarian CancerOVAREXNCT03831230
Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response
An observational study of Ovarian Cancer, run by Centre Francois Baclesse at 1 site in France.
Trial summary
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- collection of blood, urine, tumor and ascite samples
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 27 Feb 2025
- Phase
- Observational
- 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
Study population: Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
Who may be able to join
- Patient over 18 years old.
- Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
- Patient to be managed by surgery (laparoscopy and / or laparotomy).
Who cannot join
- Pregnant woman
- Persons deprived of liberty or guardianship (including curatorship)
- History of any other clinically active malignancy in the last 5 years prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.
- Conditions
- Ovarian Cancer
- Being tested
- collection of blood, urine, tumor and ascite samples
- Keywords
- ex vivo, predictive tests, tumor models
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood, urine, tumor and ascite samplesGenetic
collection of blood, urine, tumor and ascite samples during ovarian surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests
Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment
Measured: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start7 Mar 2019
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
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 Ovarian CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831230
- Sponsor's protocol ID
- 2018-A02152-53
- Acronym
- OVAREX
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2019
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thorel L, Divoux J, Lequesne J, Babin G, Morice PM, Florent R, Desmartin G, Lecouflet L, Marde Alagama C, Leconte A, Clarisse B, Briand M, Rouzier R, Gaichies L, Martin-Francoise S, Le Brun JF, Denoyelle C, Vigneron N, Jeanne C, Blanc-Fournier C, Leman R, Vaur D, Figeac M, Meryet-Figuiere M, Joly F, Weiswald LB, Poulain L, Dolivet E. The OVAREX study: Establishment of ex vivo ovarian cancer models to validate innovative therapies and to identify predictive biomarkers. BMC Cancer. 2024 Jun 7;24(1):701. doi: 10.1186/s12885-024-12429-w.
PubMed 38849726
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response
- ClinicalTrials.gov ID
- NCT03831230
- Acronym / sponsor ID
- OVAREX / 2018-A02152-53
- Conditions
- Ovarian Cancer
- Keywords
- ex vivo, predictive tests, tumor models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 5 Feb 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.
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
Key inclusion criteria (3 listed)
- Patient over 18 years old.
- Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
- Patient to be managed by surgery (laparoscopy and / or laparotomy).
Key exclusion criteria (3 listed)
- Pregnant woman
- Persons deprived of liberty or guardianship (including curatorship)
- History of any other clinically active malignancy in the last 5 years prior to inclusion
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 |
|---|---|---|
| collection of blood, urine, tumor and ascite samplescollection of blood, urine, tumor and ascite samples during ovarian surgery | Genetic | – |
Primary outcome
Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests
Time frame: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery
Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment
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 8 Aug 2025.
- Derived from this study: PubMed 38849726Thorel L, Divoux J, Lequesne J, Babin G, Morice PM, Florent R, Desmartin G, Lecouflet L, Marde Alagama C, Leconte A, Clarisse B, Briand M, Rouzier R, Gaichies L, Martin-Francoise S, Le Brun JF, Denoyelle C, Vigneron N, Jeanne C, Blanc-Fournier C, Leman R, Vaur D, Figeac M, Meryet-Figuiere M, Joly F, Weiswald LB, Poulain L, Dolivet E. The OVAREX study: Establishment of ex vivo ovarian cancer models to validate innovative therapies and to identify predictive biomarkers. BMC Cancer. 2024 Jun 7;24(1):701. doi: 10.1186/s12885-024-12429-w.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Centre Francois Baclesse 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 3 inclusion and 3 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 8 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?
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?
Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests (time frame: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery). 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 NCT03831230, 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 8 Aug 2025.