Clinical trial NCT00005095: Specimen and Data Study for Ovarian Cancer Early Detection and Prevention
Official title: Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Ovarian Cancer
Sarcoma
Uterine Leiomyomata
Vaginal Cancer
Vulvar Cancer
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.

Brief 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.

Eligibility 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

Primary outcomes:
measure: The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other
timeFrame: 1 year
Secondary outcomes:
measure: new prevention approaches and therapies for risk assessment
timeFrame: 1 year
measure: The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Lee P. Shulman, MD
role: STUDY_CHAIR
References: