Overview

This trial is active, not recruiting.

Condition ovarian cancer
Phase phase 3
Sponsor National Cancer Institute, Naples
Start date January 2010
End date April 2016
Trial size 400 participants
Trial identifier NCT01061619, MITO 12

Summary

The purpose of this study is to describe the prediagnostic symptoms and the events along the pathway to diagnosis of women with ovarian cancer, referred for first-line chemotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective

Primary Outcomes

Measure
the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
time frame: at baseline
time intervals in weeks between prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
time frame: at baseline
description of prediagnostic patient experiences according to modified Andersen's model of 'total patient delay'
time frame: at baseline

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Histological diagnosis of ovarian cancer - Indication for chemotherapy - Age > 18 years - Signed informed consent Exclusion Criteria: - Previous chemotherapy - Unable or unwilling to participate in interview

Additional Information

Official title Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study
Principal investigator Sandro Pignata, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by National Cancer Institute, Naples.