Early Detection of Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539162
First received: October 3, 2007
Last updated: June 9, 2015
Last verified: June 2015
  Purpose

The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.


Condition Intervention
Ovarian Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Rate of increase in CA 125 levels over time [ Time Frame: Once a year (Initial CA 125 test followed by another in 3 months or 12 months depending on initial assessment) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Yearly blood draw of 2 to 3 tablespoons, with CA-125 analysis performed each time. Urine specimen obtained at each UT MDACC visit.


Estimated Enrollment: 9500
Study Start Date: July 2001
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CA 125 Analysis
Participants considered to be at low risk for ovarian cancer.
Behavioral: Questionnaire
Completed during follow up visits.
Other Name: Survey

Detailed Description:

Currently, there are no effective tests to detect ovarian cancer at its earliest stage. CA-125 is an FDA approved marker for detecting if the disease has come back in women who have already had ovarian cancer. Tumor markers may be related to the status of the disease.

If you are eligible to take part in this research study, you will have blood (about 2-3 tablespoons) drawn every year while on study.

You will need to provide the name of a gynecologist or qualified healthcare professional willing to provide follow-up care, if needed.

Each time blood is drawn, the CA-125 analysis will be performed. If the CA-125 analysis shows that you are at a low risk of developing ovarian cancer, you will be asked to repeat the blood test in one year. If the CA-125 analysis shows that you are at a slightly higher risk, you will be asked to repeat the blood test in 3 months. If the CA-125 analysis shows that you are at an even higher risk, you will be asked to have a transvaginal ultrasound.

An ultrasound test uses sound waves to check the position, size, and shape of the ovaries. During a transvaginal ultrasound, a small probe will be placed in your vagina and used to create and measure sound waves. Based on the results of the transvaginal ultrasound, you and the study doctor will discuss options for further treatment or standard cancer management.

All study participants will be asked to complete a questionnaire. You will be contacted to collect follow-up information, and to make sure that you return for the follow-up blood draws. When you return for screening, your health status will be updated in your medical record before or at each visit, and any changes to your medical or cancer history will be noted. If you were not seen at a visit, the study staff will try to contact you by telephone or letter. Your medical information may also be updated using MD Anderson's Medical Informatics Section, or state tumor registries.

Your name or other identifying information will not be used at any time blood samples are drawn. Each sample will have an identifying number. Only the study coordinator will have the match between the identifying number and your identity.

Length of Participation:

Women will be enrolled on this study for up to 15 years, plus 1 year of follow-up. Your participation on this study may last up to 16 years.

This is an investigational study. Transvaginal ultrasound scans on this study are performed using FDA-approved and commercially available methods.

Up to 30,000 women will take part in this multicenter study. Up to 9500 will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants considered to be at low risk for ovarian cancer.

Criteria

Inclusion Criteria:

  1. Female, >/= 50 years old or less than 75 years old
  2. Postmenopausal (>/= 12 months amenorrhea)
  3. Have at least one ovary
  4. Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
  5. Willingness to return to MD Anderson for CA 125 blood tests annually or earlier if indicated
  6. Willingness to return to MD Anderson to undergo transvaginal ultrasound if indicated.
  7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria:

  1. Female: Less than 50 years old or older than 75 years
  2. Psychiatric or psychological or other conditions which prevent a fully informed consent.
  3. Prior removal of both ovaries.
  4. Active non-ovarian malignancy.
  5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERM (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment <12 months prior to study entry for basal cell carcinoma only.
  6. High risk for ovarian cancer : a. known mutation in BRCA1 of BRCA2.
  7. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal and one post menopausal breast cancer. These conditions can also be met using the participant and one 1st or 2nd degree female relative.
  8. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer.
  9. 1st or 2nd degree male relative with breast cancer diagnosed at any age. First degree relative defined as: children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.
  10. HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539162

Contacts
Contact: Karen H. Lu, MD 713-563-4579

Locations
United States, Iowa
John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
United States, Rhode Island
Women's and Infant's Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, Texas
Baylor -Sammons Breast Center Recruiting
Dallas, Texas, United States, 75246
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen H. Lu, MD         
University of Texas Physicians-Family Practice Associates Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539162     History of Changes
Other Study ID Numbers: ID01-022
Study First Received: October 3, 2007
Last Updated: June 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
CA 125 Algorithm
Cancer Detection
Questionnaire
Survey

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on June 29, 2015