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NCT Number: NCT01422265

Patient Reported Symptoms in Ovarian Cancer (PRECISION)

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Goodyear, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

Patient Reported Symptoms in Ovarian Cancer

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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