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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01422265
First received: August 22, 2011
Last updated: September 2, 2014
Last verified: September 2014

August 22, 2011
September 2, 2014
June 2011
July 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01422265 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Patient Reported Symptoms in Ovarian Cancer (PRECISION)
Patient Reported Symptoms in Ovarian Cancer

This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovar ian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose dise ase has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are curren tly in observation or undergoing bevacizumab maintenance treatment will be eligi ble to participate in the study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with platinum-sensitive ovarian cancer in maintenance phase of second-line treatment

Ovarian Cancer
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01422265
ML28066, 130/070
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP