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NCT Number: NCT00005095

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location status: Recruiting

Location contact

Clinical Trials Office - Robert H. Lurie Comprehensive Cancer

CONTACT

[email protected]

312-695-1301

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ca-125

Other

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

Other

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.

Other names: Questionnaire

Surgery

Procedure

Subjects will be assessed for high risk factors.

Other names: BSO, fallopian tubes, TAH, hysterectomy, bilateral salpingectomy, STIC

Primary outcomes

  1. The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other

    Time frame: 1 year

    To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies

Secondary outcomes

  1. new prevention approaches and therapies for risk assessment

    Time frame: 1 year

    To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.

  2. 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

    Time frame: 1 year

    To identify the measurements to improve the quality of life for women at increased risk for developing the disease

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Grace

CONTACT

[email protected]

312-503-4165

Takelia Walker

CONTACT

[email protected]

3125034802

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2030
Study completion
2040
First posted
Jan 27, 2003
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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