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| Sponsor: | Robert H. Lurie Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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/Ovarian Cancer (brca1, brca2) Ovarian Cancer Sarcoma Uterine Leiomyomata Vaginal Cancer Vulvar Cancer |
Other: laboratory biomarker analysis Other: screening questionnaire administration Procedure: evaluation of cancer risk factors Procedure: study of high risk factors |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Screening |
| Official Title: | Northwestern Ovarian Cancer Early Detection & Prevention Program |
| Estimated Enrollment: | 6000 |
| Study Start Date: | March 2000 |
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 |
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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
| Study ID Numbers: | CDR0000067757, NU-99G8, NU-99G7, NCI-G00-1753 |
| Study First Received: | April 6, 2000 |
| Last Updated: | November 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005095 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Neoplasms, Muscle Tissue Gonadal Disorders Vaginal Diseases Urogenital Neoplasms Ovarian Diseases Leiomyoma Uterine Cervical Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Uterine Cervical Diseases Neoplasms by Site Vulvar Neoplasms Connective Tissue Diseases Uterine Neoplasms |
Endocrine Gland Neoplasms Vaginal Neoplasms Myofibroma Ovarian Neoplasms Neoplasms by Histologic Type Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Fallopian Tube Neoplasms Fallopian Tube Diseases Adnexal Diseases Neoplasms Sarcoma Neoplasms, Connective Tissue Vulvar Diseases |