Trial record 1 of 1 for:    NCT01422265
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Patient Reported Symptoms in Ovarian Cancer (PRECISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422265
Recruitment Status : Completed
First Posted : August 23, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease
Ovarian Cancer

Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Symptoms in Ovarian Cancer
Study Start Date : June 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Primary Outcome Measures :
  1. Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression [ Time Frame: Up to 9 months ]

Secondary Outcome Measures :
  1. MDASI-OC Symptom Severity Score [ Time Frame: Up to 9 months ]
  2. MDASI-OC Symptom Interference Score [ Time Frame: By month 9 ]
  3. HRQoL scores [ Time Frame: Up to 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422265

  Hide Study Locations
United States, Arizona
Goodyear, Arizona, United States, 85338
Phoenix, Arizona, United States, 85013
Tucson, Arizona, United States, 85724
United States, California
Salinas, California, United States, 93901
Whittier, California, United States, 90603
United States, Colorado
Englewood, Colorado, United States, 80113
United States, Connecticut
Farmington, Connecticut, United States, 06030
New Britain, Connecticut, United States, 6052
United States, Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Hinsdale, Illinois, United States, 60521
Joliet, Illinois, United States, 60435
Skokie, Illinois, United States, 60076
United States, Indiana
Indianapolis, Indiana, United States, 46202
Indianapolis, Indiana, United States, 46260
United States, Maryland
Baltimore, Maryland, United States, 21237
Cumberland, Maryland, United States, 21502
United States, Montana
Missoula, Montana, United States, 59802
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, New York
Buffalo, New York, United States, 14263-0001
New York, New York, United States, 10021
Watertown, New York, United States, 57201
United States, Ohio
Canton, Ohio, United States, 44718
Cleveland, Ohio, United States, 44106-5067
Columbus, Ohio, United States, 43212
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19124
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Chattanooga, Tennessee, United States, 37403
United States, Utah
Salt Lake City, Utah, United States, 84132-0001
United States, Virginia
Annandale, Virginia, United States, 22003
United States, Washington
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT01422265     History of Changes
Other Study ID Numbers: ML28066
130/070 ( Other Identifier: Genentech )
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders