NCT05204342

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

10 years

First QC Date

January 10, 2022

Last Update Submit

January 21, 2022

Conditions

Ovarian Cancer

Keywords

Ovarian or Tubal CancerUpfront surgerysurgical thresholds

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Verify that delay in initiation of chemotherapy beyond 4 weeks

    at 5 years

  • Verify that age is a poor prognostic element

    at 5 years

  • Verify that geographic distance

    at 5 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women treated for tubo-ovarian cancer in France between 2012 and 2016

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Martha DURAES, Md

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 24, 2022

Study Start

January 1, 2012

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 24, 2022

Record last verified: 2022-01

Locations

FR(1)