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

Recruiting

• Conditions: Low-grade Serous Ovarian Carcinoma; Recurrent Invasive Borderline Serous Ovarian Cancer

• Registration Number: NCT02408536
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Istitute Nazionale Tumori - Fondazione G. Pascale; 🇮🇹 Napoli, Italy