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Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study


N/A
18 Years
80 Years
Open (Enrolling)
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Ovarian Cancer, Sarcoma, Uterine Leiomyomata, Vaginal Cancer, Vulvar Cancer

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Trial Information

Northwestern Ovarian Cancer Early Detection & Prevention Program: A Specimen and Data Study


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Identification and development of highly sensitive and specific tumor markers for the detection and management of ovarian cancer and other gynecological malignancies

Outcome Time Frame:

Outcomes will be assessed at the completion of the study.

Safety Issue:

No

Principal Investigator

Lee P. Shulman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

NU 99G8

NCT ID:

NCT00005095

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Ovarian Cancer
  • Sarcoma
  • Uterine Leiomyomata
  • Vaginal Cancer
  • Vulvar Cancer
  • 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
  • Myofibroma
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma
  • Sarcoma

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611