Ovarian CancerPro-TOCaNCT05204342
Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France
An observational study of Ovarian Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- How many people
- 22,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 30 Dec 2021
- 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: Women treated for tubo-ovarian cancer in France between 2012 and 2016
Who may be able to join
- - Diagnosic of Ovarian or Tubal Cancer C56 et C570
- +/-
- Carcinose péritonéale C786
- Tumueur maligne secondaire de la plèvre C782,
- Tumueur maligne secondaire des ganglions C770 à C779,
- Tumueur maligne secondaire du foie C787,
- Tumueur maligne secondaire du péritoine C786
Who cannot join
- autres causes de :
- Carcinose péritonéale C786
- Tumueur maligne secondaire de la plèvre C782,
- Tumueur maligne secondaire des ganglions C770 à C779,
- Tumueur maligne secondaire du foie C787,
- Tumueur maligne secondaire du péritoine C786
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence
Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian or Tubal Cancer, Upfront surgery, surgical thresholds
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the prognostic effect of the volume of activity
To study the prognostic effect of the volume of activity per center on the risk of recurrence
Measured: at 5 years
Verify that the therapeutic sequence
Verify that the therapeutic sequence of primary surgery and secondary chemotherapy is a good prognostic factor for overall and specific survival at 5 years
Measured: at 5 years
Secondary outcomes (3)
Verify that delay in initiation of chemotherapy beyond 4 weeks
Verify that delay in initiation of chemotherapy beyond 4 weeks after surgery is a poor prognostic element on overall and specific survival at 5 years
Measured: at 5 years
Verify that age is a poor prognostic element
Verify that age is a poor prognostic element for overall and specific survival at 5 years
Measured: at 5 years
Verify that geographic distance
Verify that geographic distance from a clinical center is a poor prognostic element for overall and specific survival at 5 years
Measured: at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2012
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
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 University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha DURAES, Md, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204342
- Sponsor's protocol ID
- RECHMPL21_0742
- Acronym
- Pro-TOCa
- Status last verified
- Jan 2022
- First submitted
- 10 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence
- ClinicalTrials.gov ID
- NCT05204342
- Acronym / sponsor ID
- Pro-TOCa / RECHMPL21_0742
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian or Tubal Cancer, Upfront surgery, surgical thresholds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Jan 2022 (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.
Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women treated for tubo-ovarian cancer in France between 2012 and 2016
Key inclusion criteria (7 listed)
- - Diagnosic of Ovarian or Tubal Cancer C56 et C570
- +/-
- Carcinose péritonéale C786
- Tumueur maligne secondaire de la plèvre C782,
- Tumueur maligne secondaire des ganglions C770 à C779,
Key exclusion criteria (6 listed)
- autres causes de :
- Carcinose péritonéale C786
- Tumueur maligne secondaire de la plèvre C782,
- Tumueur maligne secondaire des ganglions C770 à C779,
- Tumueur maligne secondaire du foie C787,
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
To study the prognostic effect of the volume of activity
Time frame: at 5 years
To study the prognostic effect of the volume of activity per center on the risk of recurrence
Verify that the therapeutic sequence
Time frame: at 5 years
Verify that the therapeutic sequence of primary surgery and secondary chemotherapy is a good prognostic factor for overall and specific survival at 5 years
3 secondary outcomes
Verify that delay in initiation of chemotherapy beyond 4 weeks
Time frame: at 5 years
Verify that age is a poor prognostic element
Time frame: at 5 years
Verify that geographic distance
Time frame: at 5 years
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 24 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Martha DURAES, Md principal investigator
University Hospital, Montpellier
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 University Hospital, Montpellier 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 7 inclusion and 6 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 24 Jan 2022. 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?
To study the prognostic effect of the volume of activity (time frame: at 5 years). 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 24 Jan 2022.