Patient Reported Symptoms in Ovarian Cancer (PRECISION)

Ovarian Cancer Clinical Trial

Official title:

Patient Reported Symptoms in Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422265
• Other study ID #: ML28066
• Secondary ID: 130/070
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression		Up to 9 months	No
Secondary	MDASI-OC Symptom Severity Score		Up to 9 months	No
Secondary	MDASI-OC Symptom Interference Score		By month 9	No
Secondary	HRQoL scores		Up to 9 months	No