Ovarian TumorsNCT01304043
French Observatory of Rare Malignant Tumors of the Ovary
An observational study of Ovarian Tumors, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Tumors
- What is being tested?
- chemotherapies protocols
- Type of treatment
- Injection or infusion
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Jun 2011
- 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: female with rare ovarian cancer
Who may be able to join
- age > 18 years old
- germinal or sexual cords ovary tumors histologically proven
- first line or relapse treatment
- written informed consent
Who cannot join
- mental ineptitude to understand and follow the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)
To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.
Read the detailed description
- to establish prognosis factors for the disease
- to proceed in a centralised examination of histologic laminas
- to reach in the long-term and homogenous follow-up of the patients
- to follow-up the long-term toxicities of the treatments given
- to analyse and follow-up the later fertility of the patients
- to evaluate the interest of setting a multi-disciplinary discussion forum on the Web
- Conditions
- Ovarian Tumors
- Being tested
- chemotherapies protocols
- Keywords
- ovarian tumors, rare ovarian tumors, germinal tumors, sexual cords tumors, observatory, forum
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapies protocolsDrug
Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2002
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Ray-Coquard, Physician, Principal investigator, GINECO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304043
- Sponsor's protocol ID
- TMRO
- Status last verified
- Apr 2012
- First submitted
- 9 Sep 2005
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)
- ClinicalTrials.gov ID
- NCT01304043
- Acronym / sponsor ID
- TMRO
- Conditions
- Ovarian Tumors
- Keywords
- ovarian tumors, rare ovarian tumors, germinal tumors, sexual cords tumors, observatory, forum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Feb 2011 (estimated)
- 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.
To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.
Detailed description
- to establish prognosis factors for the disease
- to proceed in a centralised examination of histologic laminas
- to reach in the long-term and homogenous follow-up of the patients
- to follow-up the long-term toxicities of the treatments given
- to analyse and follow-up the later fertility of the patients
- to evaluate the interest of setting a multi-disciplinary discussion forum on the Web
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
- female with rare ovarian cancer
Key inclusion criteria (4 listed)
- age > 18 years old
- germinal or sexual cords ovary tumors histologically proven
- first line or relapse treatment
- written informed consent
Key exclusion criteria (1 listed)
- mental ineptitude to understand and follow the study
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 |
|---|---|---|
| chemotherapies protocolsCisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV | Drug | – |
Primary outcome
Not reported in the source record.
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 20 Apr 2012.
- information for patients, discussion forum about "difficult" cases, therapeutic strategy for patients presenting rare ovarian tumorLink provided by the sponsor.
Related trials for Ovarian Tumors
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast 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.
Isabelle Ray-Coquard, Physician principal investigator
GINECO
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 Tumors, run by ARCAGY/ GINECO GROUP 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 4 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 20 Apr 2012. 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.
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 20 Apr 2012.