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

This study is currently recruiting participants.
Verified February 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01422265
First received: August 22, 2011
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Symptoms in Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MDASI-OC Symptom Severity Score [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  • MDASI-OC Symptom Interference Score [ Time Frame: By month 9 ] [ Designated as safety issue: No ]
  • HRQoL scores [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: June 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422265

Contacts
Contact: Please reference Study ID Number: ML28066 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 21 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01422265     History of Changes
Other Study ID Numbers: ML28066, 130/070
Study First Received: August 22, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013