Clinical trial NCT01422265: Patient Reported Symptoms in Ovarian Cancer (PRECISION)
Official title: Patient Reported Symptoms in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
timeFrame: Up to 9 months
Secondary outcomes:
measure: MDASI-OC Symptom Severity Score
timeFrame: Up to 9 months
measure: MDASI-OC Symptom Interference Score
timeFrame: By month 9
measure: HRQoL scores
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Goodyear
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Salinas
country: United States
state: California
city: Whittier
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: New Britain
country: United States
state: Connecticut
city: Augusta
country: United States
state: Georgia
city: Hinsdale
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Cumberland
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Watertown
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Annandale
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: