Pathway to Diagnosis of Ovarian Cancer (MITO-12)
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ClinicalTrials.gov Identifier: NCT01061619 |
Recruitment Status :
Active, not recruiting
First Posted : February 3, 2010
Last Update Posted : March 4, 2021
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Condition or disease |
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Ovarian Cancer |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | November 2021 |
Estimated Study Completion Date : | November 2021 |

- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061619

Principal Investigator: | Sandro Pignata, M.D., Ph.D. | National Cancer Institute, Naples | |
Principal Investigator: | Francesco Perrone, M.D., Ph.D. | National Cancer Institute, Naples | |
Principal Investigator: | Alessandro Morabito, M.D., | National Cancer Institute, Naples | |
Principal Investigator: | Ciro Gallo, M.D., Ph.D. | University of Campania "Luigi Vanvitelli" | |
Principal Investigator: | Jane Bryce, MSN | National Cancer Institute, Naples | |
Principal Investigator: | Marzia Falanga, BSN | S. Giuseppe Moscati Hospital, Avellino | |
Principal Investigator: | Carmen Pisano, MD | National Cancer Institute, Naples | |
Principal Investigator: | Marilina Piccirillo, MD | National Cancer Institute, Naples | |
Principal Investigator: | Massimo Di Maio, M.D. | National Cancer Institute, Naples |
Responsible Party: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT01061619 |
Other Study ID Numbers: |
MITO 12 |
First Posted: | February 3, 2010 Key Record Dates |
Last Update Posted: | March 4, 2021 |
Last Verified: | March 2021 |
prediagnostic symptoms sentinel events pathway to diagnosis |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |