Patient Reported Symptoms in Ovarian Cancer (PRECISION)

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT01422265
• Lead Sponsor: Genentech, Inc.

Brief Summary

This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred \> 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred > 6 months after platinum-based chemotherapy
• This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
• Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
• Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
• Have a valid email address and access to the internet
• Provide voluntary written informed consent
• Speak and read English fluently

Exclusion Criteria

• Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
• Another primary diagnosis of cancer in a different site

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
MDASI-OC Symptom Severity Score	Up to 9 months
MDASI-OC Symptom Interference Score	By month 9
HRQoL scores	Up to 9 months