Status:

NOT_YET_RECRUITING

Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial

Lead Sponsor:

University Hospital, Tours

Conditions:

Epithelial Ovarian Cancer

Eligibility:

FEMALE

18-85 years

Phase:

NA

Brief Summary

In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker assay) will enable faster, more targeted diagnosis and management of epithelial ovarian cancer recurrence than t...

Eligibility Criteria

Inclusion

  • Women aged 18 or over and less than 85 years old
  • With proven FIGO stage I to IV epithelial ovarian cancer (ovary/tumor/peritoneum)
  • Women in remission after first-line chemotherapy, with a normal CA125 less than 4 months old at study entry (end of first-line chemotherapy).
  • Woman having completed chemotherapy at least 6 months previously
  • Written informed consent
  • French social security

Exclusion

  • Any physical or psychiatric condition that may interfere with the patient's cooperation in data collection
  • Patient with normal CA125 at initial diagnosis of epithelial ovarian cancer
  • Patient under guardianship
  • Patient deprived of liberty

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2028

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT05991752

Start Date

November 1 2023

End Date

November 1 2028

Last Update

August 15 2023

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