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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00005095 |
Purpose
RATIONALE: Screening may help doctors find ovarian cancer sooner, when it may be easier to treat. It may also help doctors plan better treatment for ovarian cancer.
PURPOSE: This clinical trial is studying screening methods for identifying women who are at increased risk for developing ovarian cancer.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Hereditary Breast and Ovarian Cancer Syndrome Ovarian Cancer Sarcoma Uterine Fibroids Vaginal Cancer Vulvar Cancer |
Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: study of high risk factors |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Northwestern Ovarian Cancer Early Detection & Prevention Program |
Subjects blood is collected their follow-up appointments.
| Estimated Enrollment: | 6000 |
| Study Start Date: | March 2000 |
| Estimated Primary Completion Date: | December 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
High Risk for Ovarian Cancer
Women who are at high risk of ovarian cancer based on family or personal medical history.
|
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 symptoms and other predictors of ovarian cancer will be administered to the subjects.
Procedure: study of high risk factors
Subjects will be assessed for high risk factors.
|
OBJECTIVES:
OUTLINE: Patients complete an extensive personal and family medical history questionnaire and meet with a genetic counselor to review the questionnaire and for a risk assessment at baseline. Patients also undergo transvaginal ultrasound, clinical breast, pelvic, and rectal exam, and CA-125 testing at baseline and then every 6 months thereafter, or as determined by the physician. Patients also complete additional questionnaires periodically.
Patients undergo blood sample collection periodically for research studies, including molecular, biochemical, functional, and genetic marker studies.
The referring physician will be notified of any abnormal test results. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
Asymptomatic AND considered to be at increased risk for developing ovarian cancer, as defined by one of the following:
Undergoing surgery for a gynecologic condition, including any of the following:
PATIENT CHARACTERISTICS:
Age
Contacts and Locations| 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 cancer@northwestern.edu | |
| Study Chair: | Lee P. Shulman, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Lee P. Shulman, M.D., Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00005095 History of Changes |
| Other Study ID Numbers: | NU 99G8, P30CA060553, NU-99G8, NCI-G00-1753 |
| Study First Received: | April 6, 2000 |
| Last Updated: | February 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
ovarian epithelial cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) fallopian tube cancer ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer |
endometrial cancer uterine sarcoma vaginal cancer cervical cancer vulvar cancer uterine leiomyomata |
|
Endometrial Neoplasms Uterine Cervical Neoplasms Leiomyoma Ovarian Neoplasms Myofibroma Vaginal Neoplasms Vulvar Neoplasms Fallopian Tube Neoplasms Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases |
Genital Diseases, Female Uterine Cervical Diseases Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms, Connective Tissue Connective Tissue Diseases Vaginal Diseases Vulvar Diseases Fallopian Tube Diseases |
