Borderline Ovarian TumorsOPTIBOTNCT03690440
Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor
An observational study of Borderline Ovarian Tumors, run by Institut Curie at 11 sites in France.
Trial summary
Retrospective and prospective multi-center study Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility Objectives: Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Borderline Ovarian Tumors
- How many people
- 176 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Jun 2018to 31 Dec 2018
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.
Who may be able to join
- Women with history of Borderline Ovarian Tumor (BOT).
- Women who have had first a fertility-sparing surgery.
- Women old enough to procreate (= 45 years) during their first surgery.
- Women having agreed to participate in the previous study "Observatoire sur les Tumeurs Malignes Rares de l'Ovaire" (TMRO).
- Women who have not expressed their opposition to the research.
Who cannot join
- The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut Bergonié
Bordeaux, 33076
Centre Jean PERRIN
Clermont-Ferrand, 63011
Centre Leon Berard
Lyon, 69373
Institut Paoli CALMETTES
Marseille, 13009
Institut Curie, Paris
Paris, 75005
Hôpital Européen Goerges POMPIDOU
Paris, 75015
Goupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020
Centre Hospitalier Intercommunal Poissy - Saint-Germain
Poissy, 78300
Institut Curie - Saint-Cloud
Saint-Cloud, 92210
IUCT Oncopole - Institut Claudius Regaud
Toulouse, 31400
Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN
Vandœuvre-lès-Nancy, 54500
About this study
Official title: OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)
Retrospective and prospective multi-center study
Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility
Read more
Objectives:
- Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
- Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Origin and nature of the specific data:
- Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
- Collection of retrospective further informations in the participating centers
- Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .
Data traffic :
TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.
The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.
Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.
- Conditions
- Borderline Ovarian Tumors
- Keywords
- Borderline Ovarian Tumor (BOT), Fertility-sparing surgery, Gynecology, Oncology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
Univariate and multivariate analysis on patients modalities of care and fertility , through medical history and questionnaires (study based on patients who were included in the previous study "Observatoire Sur Les Tumeurs Malignes Rares de l'Ovaire" (TMRO french network)
Measured: December 2018
Secondary outcomes (1)
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Test of a published fertility prognostic tool in this population. Estimation of the precision of the estimation of alive birth in our cohort will be done by determining the difference between predicted live birth and observed rate of live birth.
Measured: December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 Jun 2018
- Primary completion30 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Ovarian TumorsStudies 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
- Other
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP
- Responsible party
- Sponsor
- Investigators
- Delphine HEQUET, MD PhD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690440
- Sponsor's protocol ID
- IC 2017-09
- Other IDs
- N° : 2018-A00092-53
- Acronym
- OPTIBOT
- Status last verified
- Mar 2019
- First submitted
- 4 Jul 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)
- ClinicalTrials.gov ID
- NCT03690440
- Acronym / sponsor ID
- OPTIBOT / IC 2017-09
- Conditions
- Borderline Ovarian Tumors
- Keywords
- Borderline Ovarian Tumor (BOT), Fertility-sparing surgery, Gynecology, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- ARCAGY/ GINECO GROUP
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Oct 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.
Retrospective and prospective multi-center study
Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility
Objectives:
- Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
- Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Origin and nature of the specific data:
- Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
- Collection of retrospective further informations in the participating centers
- Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .
Data traffic :
TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.
The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.
Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.
Key inclusion criteria (5 listed)
- Women with history of Borderline Ovarian Tumor (BOT).
- Women who have had first a fertility-sparing surgery.
- Women old enough to procreate (= 45 years) during their first surgery.
- Women having agreed to participate in the previous study "Observatoire sur les Tumeurs Malignes Rares de l'Ovaire" (TMRO).
- Women who have not expressed their opposition to the research.
Key exclusion criteria (1 listed)
- The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
Time frame: December 2018
Univariate and multivariate analysis on patients modalities of care and fertility , through medical history and questionnaires (study based on patients who were included in the previous study "Observatoire Sur Les Tumeurs Malignes Rares de l'Ovaire" (TMRO french network)
1 secondary outcome
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Time frame: December 2018
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 30 Oct 2019.
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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.
Delphine HEQUET, MD PhD study director
Institut Curie
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Ovarian Tumors, run by Institut Curie at 11 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 5 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors (time frame: December 2018). 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 30 Oct 2019.