DOD Long-Term Survivors of Ovarian Cancer

NCT02321735 | Unknown

• 2 other identifiers: 2014P000798W81XWH-13-1-0413
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

: Stages III and IV serum ovarian cancer are the most lethal of all gynecologic cancers; however, some advanced-stage ovarian cancer patients are long-term survivors. These patients may provide the key to long-term survival and bring hope to all women with Stages III and IV ovarian cancer. There is no meaningful explanation of why some patients with ovarian cancer become long-term survivors and what their quality of life is long after their initial diagnosis. This research project will specifically determine molecular features within tumors along with genetic, quality of life, and lifestyle features that predict for long-term survival for patients with Stages III and IV ovarian cancer. It will bring together sophisticated molecular techniques, researchers with longstanding interest, a wide spectrum of consumer advocates (a number being long-term survivors), and quality of life experts to analyze the most carefully maintained patient database in the world-the Gynecologic Oncology Group database. We anticipate the results from this project will identify specific biochemical pathways and genetic features associated with long-term survival that can be used to improve the treatment, survival, and survivorship of patients with this disease. There is clearly something unique among patients who survive Stage III or IV ovarian cancer long term, and we believe that when we understand what this is, we can increase the number of long- and longer-term survivors.

Conditions

Ovarian Cancer

Keywords

Long-Term Survivor; Genomic; Survivorship; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life questionnaire

  5 years

Study Arms (1)

Long-Term Ovarian Cancer survivors

OTHER

Genomic, immunologic and psychosocial characterization of Long-Term survivors of ovarian cancer. This will involve a Quality of Life Questionaire.

Behavioral: Quality of life questionaire

Interventions

Quality of life questionaire BEHAVIORAL

Patients will participate in a QOL questionaire followed by a phone interview

Long-Term Ovarian Cancer survivors

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage III/IV high grade epithelial ovarian cancer diagnosed at least 10 years ago

You may not qualify if:

• early stage, low grade ovarian cancer diagnosed less than 10 years ago

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of California, Irvine: collaborator

Study Sites (1)

Massachusetts General Hospital (The General Hospital Corp)

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Birrer, MD PhD

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Fulci, PhD

CONTACT

617-643-5130; gfulci@partners.org

Michael Birrer, MD PhD

CONTACT

617-726-8624; mbirrer@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Gynecologic Medical Oncology

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)