Pathway to Diagnosis of Ovarian Cancer (MITO-12)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01061619
First received: February 2, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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 Phase
Ovarian Cancer
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pathway to Diagnosis of Ovarian Cancer: Observational Retrospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • time intervals in weeks between prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • description of prediagnostic patient experiences according to modified Andersen's model of 'total patient delay' [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
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
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico
Napoli, Italy, 80131
Università Federico II, Cattedra di Oncologia Medica
Napoli, Italy
Azienda Ospedaliera D. Cotugno
Napoli, Italy, 80131
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. Second University of Naples
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

No publications provided

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01061619     History of Changes
Other Study ID Numbers: MITO 12
Study First Received: February 2, 2010
Last Updated: January 2, 2014
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014