Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
Conditions
Cervical Cancer - Endometrial Cancer - Fallopian Tube Cancer - Hereditary Breast/Ovarian Cancer (brca1, brca2) - Ovarian Cancer - Sarcoma - Uterine Leiomyomata - Vaginal Cancer - Vulvar Cancer
Conditions: official terms
Fallopian Tube Neoplasms - Leiomyoma - Myofibroma - Ovarian Neoplasms - Uterine Cervical Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Conditions: Keywords
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
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: laboratory biomarker analysis Type: Other
Name: screening questionnaire administration Type: Other
Name: study of high risk factors Type: Procedure
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Status: Recruiting
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer - 312-695-1301 - cancer@northwestern.edu
Start Date
March 2000
Sponsors
Northwestern University
Source
Northwestern University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page