Patient Reported Symptoms in Ovarian Cancer (PRECISION)
2 other identifiers
observational
56
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2011
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 2, 2016
November 1, 2016
3.8 years
August 22, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
MDASI-OC Symptom Severity Score
Up to 9 months
MDASI-OC Symptom Interference Score
By month 9
HRQoL scores
Up to 9 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (31)
Unknown Facility
Goodyear, Arizona, 85338, United States
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Salinas, California, 93901, United States
Unknown Facility
Whittier, California, 90603, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
Farmington, Connecticut, 06030, United States
Unknown Facility
New Britain, Connecticut, 6052, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Hinsdale, Illinois, 60521, United States
Unknown Facility
Joliet, Illinois, 60435, United States
Unknown Facility
Skokie, Illinois, 60076, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Baltimore, Maryland, 21237, United States
Unknown Facility
Cumberland, Maryland, 21502, United States
Unknown Facility
Missoula, Montana, 59802, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Buffalo, New York, 14263-0001, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Watertown, New York, 57201, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Cleveland, Ohio, 44106-5067, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19124, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Chattanooga, Tennessee, 37403, United States
Unknown Facility
Salt Lake City, Utah, 84132-0001, United States
Unknown Facility
Annandale, Virginia, 22003, United States
Unknown Facility
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 23, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11