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NCT01061619 Clinical Trial

Pathway to Diagnosis of Ovarian Cancer

Ovarian Cancer Clinical Trial

— MITO-12  

Official title:
Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01061619
Other study ID # MITO 12
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2010
Est. completion date November 2024

Study information
Verified date March 2023
Source National Cancer Institute, Naples
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium UZ Leuven-Gynecological Oncology, Leuven
Germany Charité Universitätsmedizin Berlin Campus Virchow-Klinikum / Frauenklinik Berlin
Italy Ospedale Mazzoni Ascoli Piceno
Italy Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C Aviano PN
Italy IRCCS Oncologico Bari, Oncologia Medica Bari BA
Italy Policlinico Universitario Bari
Italy Universita di Bari Policinico I Clinical Ostetrica e Ginecologica Bari
Italy Azienda Ospedaliera G. Rummo Benevento BN
Italy Ospedale Fatebenefratelli Benevento
Italy Ospedale Fatebenefratelli, U.O. di Oncologia Benevento BN
Italy Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia Bergamo BG
Italy Ospedale Senatore Antonio Perrino Brindisi
Italy Universita Cattolica del Sacro Cuore Campobasso
Italy Università Cattolica del Sacro Cuore, Dipartimento di Oncologia Campobasso CB
Italy Ospedale A. Manzoni Lecco
Italy Azienda Ospedaliera C. Poma Mantova MN
Italy Istituto Nazionale Tumori Milano
Italy A.O. Univeristaria Policlinico Modena
Italy Azienda Ospedaliera D. Cotugno Napoli
Italy Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico Napoli
Italy Università Federico II, Cattedra di Oncologia Medica Napoli
Italy Azienda Ospedaliera V. Cervello Palermo PA
Italy Ospedale S. Massimo, Day Hospital Oncologico Penne PE
Italy Ospedale Silvestrini Perugia
Italy Ospedale Civile S. Spirito Pescara
Italy A.O. S. Maria degli Angeli Pordenone
Italy Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia Roma
Italy Ospedale S. Chiara Trento TN
Italy A.O. di Udine S. Maria della Misericordia Udine
Italy Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica Vicenza VI

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Naples

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

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