Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
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Purpose
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 | 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: study of high risk factors |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study |
- 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. ] [ Designated as safety issue: No ]
- Identification of new prevention approaches and therapies [ Time Frame: Outcomes will be assessed at the completion of the study. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Subjects blood and other specimens are collected their follow-up clinic 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 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.
|
Detailed Description:
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| 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:
Considered to be at increased risk for developing ovarian cancer, as defined by one of the following:
- Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer
- Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor
- A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer
- Increased risk as deemed by a certified genetic counselor
Undergoing surgery for a gynecologic condition, including any of the following:
- Diagnosis of a reproductive cancer
- Benign gynecological condition (e.g., uterine leiomyomata, endometriosis, pelvic inflammatory disease, or follicular or corpus luteum ovarian cysts)
- Highly suspicious adnexal mass
- Risk-reducing prophylactic oophorectomy
PATIENT CHARACTERISTICS:
Age
- Between the ages of 18 and 80
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
Additional Information:
No publications provided
| Responsible Party: | Lee Shulman, Chief, Division of Clinical Genetics, 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: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
ovarian epithelial cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) fallopian tube cancer ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer |
endometrial cancer vaginal cancer cervical cancer vulvar cancer uterine sarcoma uterine leiomyomata |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Vaginal Neoplasms Vulvar Neoplasms Fallopian Tube Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Connective Tissue |
Endocrine Gland Neoplasms Ovarian Diseases Neoplasms, Glandular and Epithelial Leiomyoma Myofibroma Adenoma Sarcoma Uterine Diseases Genital Diseases, Female Uterine Cervical Diseases Connective Tissue Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Vaginal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013