Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

NCT00005095 | Recruiting DMC

• 4 other identifiers: NU 99G8P30CA060553NU-99G8NCI-G00-1753
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• new prevention approaches and therapies for risk assessment

  1 year

• 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

  1 year

Study Arms (3)

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.

Other: Ca-125; Other: screening questionnaire administration; Procedure: Surgery

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 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.

High Risk for 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.

Also known as: Questionnaire

High Risk for Ovarian Cancer

Surgery PROCEDURE

Subjects will be assessed for high risk factors.

Also known as: BSO, fallopian tubes, TAH, hysterectomy, bilateral salpingectomy, STIC

High Risk for Ovarian Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

RECRUITING

Related Links

• Ovarian, Fallopian Tube, and Primary Peritoneal Cancer Research

Biospecimen

Retention: SAMPLES WITH DNA

Subject's blood and other specimens are collected their follow-up clinic appointments, as needed

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome; Ovarian Neoplasms; Sarcoma; Myofibroma; Vaginal Neoplasms; Vulvar Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

CA-125 Antigen; Surveys and Questionnaires; Surgical Procedures, Operative; Buthionine Sulfoximine; Hysterectomy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Breast Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Connective Tissue; Connective Tissue Diseases; Vaginal Diseases; Vulvar Diseases; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Mucins; Mucoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Biological Factors; Epitopes; Biomarkers, Tumor; Biomarkers; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Methionine Sulfoximine; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Lee P. Shulman, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Central Study Contacts

Takelia Walker

CONTACT

3125034802; takelia-watson@northwestern.edu

Anne Grace

CONTACT

312-503-4165; anne@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: March 1, 2000
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2040
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)