Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00005095
• Other study ID #: NU 99G8
• Secondary ID: P30CA060553NU-99
• Status: Recruiting
• Start date: March 2000
• Est. completion date: December 2040

Study information

• Verified date: June 2023
• Source: Northwestern University
• Contact: Kisha Hope
• Phone: 312-503-3857
• Email: kisha.hope[@]northwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2040
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Procedure:
• Surgery
Subjects will be assessed for high risk factors.

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other	To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies	1 year
Secondary	new prevention approaches and therapies for risk assessment	To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.	1 year
Secondary	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	To identify the measurements to improve the quality of life for women at increased risk for developing the disease	1 year

External Links

•   Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Research