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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 4, 2021
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
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

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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Information from the National Library of Medicine

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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
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Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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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    
Other Study ID Numbers: MITO 12
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Keywords provided by National Cancer Institute, Naples:
prediagnostic symptoms
sentinel events
pathway to diagnosis
Additional relevant MeSH terms:
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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