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Pathway to Diagnosis of Ovarian Cancer (MITO-12)

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute, Naples
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01061619
First received: February 2, 2010
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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: July 2013
Estimated Primary Completion Date: June 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061619

Contacts
Contact: Sandro Pignata, M.D., Ph.D. +39 081 5903637 sandro.pignata@istitutotumori.na.it
Contact: Jane Bryce, M.S.N. +39 081 5903571 jane.bryce@usc-intnapoli.net

Locations
Belgium
UZ Leuven-Gynecological Oncology, Recruiting
Leuven, Belgium
Germany
Charité Universitätsmedizin Berlin Campus Virchow-Klinikum / Frauenklinik Recruiting
Berlin, Germany
Italy
IRCCS Oncologico Bari, Oncologia Medica Recruiting
Bari, BA, Italy, 70126
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia Recruiting
Bergamo, BG, Italy, 24128
Azienda Ospedaliera G. Rummo Recruiting
Benevento, BN, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia Recruiting
Benevento, BN, Italy, 82100
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia Recruiting
Campobasso, CB, Italy, 86100
Azienda Ospedaliera C. Poma Recruiting
Mantova, MN, Italy, 46100
Azienda Ospedaliera V. Cervello Recruiting
Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico Recruiting
Penne, PE, Italy, 65017
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C Recruiting
Aviano, PN, Italy, 33081
Ospedale S. Chiara Recruiting
Trento, TN, Italy, 38100
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica Recruiting
Vicenza, VI, Italy, 36100
Ospedale Mazzoni Recruiting
Ascoli Piceno, Italy
Policlinico Universitario Recruiting
Bari, Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica Recruiting
Bari, Italy
Ospedale Fatebenefratelli Recruiting
Benevento, Italy
Ospedale Senatore Antonio Perrino Recruiting
Brindisi, Italy
Universita Cattolica del Sacro Cuore Recruiting
Campobasso, Italy
Ospedale A. Manzoni Recruiting
Lecco, Italy
Istituto Nazionale Tumori Recruiting
Milano, Italy
A.O. Univeristaria Policlinico Recruiting
Modena, Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico Recruiting
Napoli, Italy, 80131
Università Federico II, Cattedra di Oncologia Medica Recruiting
Napoli, Italy
Azienda Ospedaliera D. Cotugno Recruiting
Napoli, Italy, 80131
Ospedale Silvestrini Recruiting
Perugia, Italy
Ospedale Civile S. Spirito Recruiting
Pescara, Italy
A.O. S. Maria degli Angeli Recruiting
Pordenone, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia Recruiting
Roma, Italy
A.O. di Udine S. Maria della Misericordia Recruiting
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: February 27, 2013
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 May 19, 2013