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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 28, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Study Description
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Brief 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.

Condition or disease
Ovarian Cancer

Study Design
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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
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: at baseline ]
  2. time intervals in weeks between prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) [ Time Frame: at baseline ]
  3. description of prediagnostic patient experiences according to modified Andersen's model of 'total patient delay' [ Time Frame: at baseline ]

Eligibility Criteria
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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
Study Population
Patients with confirmed diagnosis of ovarian cancer, presenting for first-line chemotherapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
Belgium
UZ Leuven-Gynecological Oncology,
Leuven, Belgium
Germany
Charité Universitätsmedizin Berlin Campus Virchow-Klinikum / Frauenklinik
Berlin, Germany
Italy
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia
Bergamo, BG, Italy, 24128
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy, 86100
Azienda Ospedaliera C. Poma
Mantova, MN, Italy, 46100
Azienda Ospedaliera V. Cervello
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico
Penne, PE, Italy, 65017
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C
Aviano, PN, Italy, 33081
Ospedale S. Chiara
Trento, TN, Italy, 38100
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica
Vicenza, VI, Italy, 36100
Ospedale Mazzoni
Ascoli Piceno, Italy
Policlinico Universitario
Bari, Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica
Bari, Italy
Ospedale Fatebenefratelli
Benevento, Italy
Ospedale Senatore Antonio Perrino
Brindisi, Italy
Universita Cattolica del Sacro Cuore
Campobasso, Italy
Ospedale A. Manzoni
Lecco, Italy
Istituto Nazionale Tumori
Milano, Italy
A.O. Univeristaria Policlinico
Modena, Italy
Azienda Ospedaliera D. Cotugno
Napoli, Italy, 80131
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy, 80131
Università Federico II, Cattedra di Oncologia Medica
Napoli, 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
A.O. di Udine S. Maria della Misericordia
Udine, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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
More Information
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01061619     History of Changes
Other Study ID Numbers: MITO 12
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by National Cancer Institute, Naples:
prediagnostic symptoms
sentinel events
pathway to diagnosis

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type