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

March 23, 2023 updated by: National Cancer Institute, Naples
The purpose of this study is to retrospectively evaluate treatments and outcomes of patients with low grade serous ovarian carcinomas in Italy.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Napoli, Italy
        • Recruiting
        • Istitute Nazionale Tumori - Fondazione G. Pascale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years
progression free survival
Time Frame: 2 years
2 years
risk of recurrence in patients with low-grade serous ovarian carcinoma
Time Frame: two years
two years
number of patients with objective tumor response after receiving chemotherapy
Time Frame: 6 months
6 months
number of patients with objective tumor response after receiving hormone therapy
Time Frame: 6 months
6 months
number of patients with objective tumor response after receiving combination hormonal and chemotherapy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MITO 22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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