Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT00005095

Conditions

Cervical Cancer

Endometrial Cancer

Fallopian Tube Cancer

Hereditary Breast/Ovarian Cancer (brca1, brca2)

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ca-125

screening questionnaire administration

Surgery

Study Details

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.

Conditions

Cervical Cancer

Endometrial Cancer

Fallopian Tube Cancer

Hereditary Breast/Ovarian Cancer (brca1, brca2)

Ovarian Cancer

Study ID

NCT00005095

Start date

Mar, 2000

Status verified date

Feb, 2025

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Suspected or diagnosed gynecological condition

Women who are planning to undergo surgery for their gynecological condition

Control Group

Healthy subjects with no history of cancer and at general risk.

Interventions

Ca-125

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.

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.

Surgery

Subjects will be assessed for high risk factors.

Primary outcome measure

  • The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Takelia Walker

3125034802takelia-watson@northwestern.edu

Anne Grace

312-503-4165anne@northwestern.edu

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Recruiting

Chicago, Illinois, United States, 60611-3013

Contacts

Clinical Trials Office - Robert H. Lurie Comprehensive Cancer

312-695-1301cancer@northwestern.edu

More Information

Sponsor

Northwestern University

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2025-02-28.