Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
|ClinicalTrials.gov Identifier: NCT00005095|
Recruitment Status : Recruiting
First Posted : January 27, 2003
Last Update Posted : September 30, 2016
RATIONALE: To improve strategies for detection and prevention of early-stage disease.
PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.
|Condition or disease||Intervention/treatment|
|Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Ovarian Cancer Sarcoma Uterine Leiomyomata Vaginal Cancer Vulvar Cancer||Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: study of high risk factors|
- To identify and develop highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies.
- To identify new prevention approaches and therapies.
- To identify measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer.
OUTLINE: Subjects undergo periodic specimen and data collection for research studies, including molecular, biochemical, functional, and genetic marker studies. Participants may have samples of blood, tissue, or body fluids (such as ascites, pleural fluid or urine), or any combination of the aforementioned samples obtained to develop tumor markers to detect early stage or recurrent ovarian cancer.
The results from the biomarker research studies will not be reported to the patient or the physician. In the future, if any of the experimental tumor markers are found to be effective in detecting early stage ovarian cancer, and the patient's result is abnormal, the patient and physician will be notified.
Subjects may be asked to complete a combination of questionnaires designed to evaluate psychological functioning among women enrolled in a comprehensive ovarian cancer early detection program who are at increased risk for developing disease as compared to women currently diagnosed with ovarian cancer.
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|Official Title:||Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study|
|Study Start Date :||March 2000|
|Estimated Primary Completion Date :||December 2020|
High Risk for Ovarian Cancer
Women who are at increased risk of ovarian cancer based on family or personal medical history who are participating in the Northwestern Ovarian Cancer Early Detection and Prevention Program clinic.
Other: laboratory biomarker analysis
Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.Other: screening questionnaire administration
Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.Procedure: study of high risk factors
Subjects will be assessed for high risk factors.
- Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies [ Time Frame: Outcomes will be assessed at the completion of the study. ]
- Identification of new prevention approaches and therapies [ Time Frame: Outcomes will be assessed at the completion of the study. ]
- Identification of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer [ Time Frame: Outcomes will be assessed at the completion of the study. ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005095
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Recruiting|
|Chicago, Illinois, United States, 60611-3013|
|Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 firstname.lastname@example.org|
|Study Chair:||Lee P. Shulman, MD||Robert H. Lurie Cancer Center|