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

Low-grade Serous Ovarian Carcinoma Clinical Trial

— MITO 22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02408536
• Other study ID #: MITO 22
• Status: Recruiting
• Start date: October 2014
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Francesco Perrone, MD PhD
• Phone: +39 081 5903571
• Email: datamanager[@]usc-intnapoli.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Low-grade Serous Ovarian Carcinoma
• Ovarian Neoplasms
• Recurrent Invasive Borderline Serous Ovarian Cancer

Locations

Country	Name	City	State
Italy	Istitute Nazionale Tumori - Fondazione G. Pascale	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

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