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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05204342
Other study ID # RECHMPL21_0742
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 30, 2021

Study information

Verified date January 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 22500
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria: - - 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 Exclusion criteria: - 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

Study Design


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at 5 years
Primary 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 at 5 years
Secondary 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 at 5 years
Secondary Verify that age is a poor prognostic element Verify that age is a poor prognostic element for overall and specific survival at 5 years at 5 years
Secondary 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 at 5 years
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