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MITO 22: Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer

Sponsor
National Cancer Institute, Naples (Other)
Overall Status
Recruiting
CT.gov ID
NCT02408536
Collaborator
(none)
150
Enrollment
1
Location
93
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Observational Retrospective Study on Treatment and Outcomes in Patients With Low-grade Serous Ovarian Cancer
    Study Start Date :
    Oct 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Jul 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Single cohort

    Retrospective analysis of all patients diagnosed, from 01/01/2000 to 01/01/2014, with low-grade serous ovarian cancer or invasive recurrence after surgery for borderline serous carcinoma

    Outcome Measures

    Primary Outcome Measures

    1. risk of recurrence in patients with low-grade serous ovarian carcinoma [two years]

    2. number of patients with objective tumor response after receiving chemotherapy [6 months]

    3. number of patients with objective tumor response after receiving hormone therapy [6 months]

    4. number of patients with objective tumor response after receiving combination hormonal and chemotherapy [6 months]

    5. progression free survival [2 years]

    6. overall survival [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis low-grade serous ovarian carcinoma

    • OR invasive recurrence after surgical resection of borderline serous ovarian carcinoma

    • Availability of archival tumor specimen (paraffin embedded block) for central analysis and evaluation for mutations

    • Age > 18 years

    • Signed informed consent

    Exclusion Criteria:

    • High-grade serous, mucinous, endometrioid, or any other non-low-grade serous ovarian carcinoma

    • Unavailability of archival tumor specimen

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istitute Nazionale Tumori - Fondazione G. Pascale Napoli Italy

    Sponsors and Collaborators

    • National Cancer Institute, Naples

    Investigators

    • Principal Investigator: Sandro Pignata, MD PhD, NCI Naples
    • Principal Investigator: Chiara Della Pepa, MD, NCI Naples
    • Principal Investigator: Francesco Perrone, MD PhD, NCI Naples

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute, Naples
    ClinicalTrials.gov Identifier:
    NCT02408536
    Other Study ID Numbers:
    • MITO 22
    First Posted:
    Apr 3, 2015
    Last Update Posted:
    Mar 4, 2021
    Last Verified:
    Mar 1, 2021
    Keywords provided by National Cancer Institute, Naples
    chemotherapy
    hormone therapy
    borderline
    low-grade
    serous ovarian cancer
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Mar 4, 2021