Early Detection of Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 30, 2014
Last verified: April 2014
  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 2016 (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 recurrence of disease in women who have already had ovarian cancer.

Women who are at least 50 years old, who are post-menopausal, are eligible for this study. Patients will have their blood drawn each year for the duration of the study. The amount of blood drawn will be about 2 to 3 tablespoons.

Women will need to provide the name of a gynecologist or qualified healthcare professional willing to provide follow up care if it is indicated.

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

An ultrasound test uses sound waves to evaluate the position, size, and shape of the ovaries. During an ultrasound, a small probe will be used to generate and measure sound waves. It will be placed in the vagina. Based on the results of the transvaginal ultrasound, patients and their physician will discuss options for management. At this point, standard clinical management ensues.

Patient's will be asked to complete a questionnaire. Patient's will be contacted to obtain follow up information, and to ensure that they return for their blood draws. When patients return for screening, their health status will be updated prior to, or at each visit. Any changes to the participant's medical or cancer history will be obtained at that time. Attempts will be made to contact patients by telephone or letter that are not seen during visits. Updates to each participant's cancer history may also be obtained via M. D. Anderson's medical informatics section, if an M. D. Anderson patient, or state tumor registries.

Patients' names will not be used at any time. Each sample will have an identifying number. Only the study coordinator will have the match between the identifying number and the patient's name.

This is an investigational study. A total of 30,000 women will take part in this study. Women will be enrolled in the study during Year 1 thru Year 15 of the study. An additional year, Year 16, will be for follow-up. For example, a woman enrolled in the beginning of Year 1 will participate for sixteen years. A woman enrolled in the beginning of Year 2 will participate for fifteen years and a woman enrolled in the beginning of Year 3 will participate for fourteen years and so on. Women will be enrolled at John Stoddard Cancer Center, Des Moines, Iowa, Women's and Infant's Hospital in Providence, Rhode Island; The University of Texas M.D. Anderson Cancer Center, Houston, Texas, UT Southwestern, Dallas, Texas and Carol G. Simon Cancer Center, Morristown, New Jersey. In order to increase community participation in Houston, Texas a free-standing physician practice, Obstetrics and Gynecology Associates (OGA), has been been added.

  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 UTMD Anderson Cancer Center (UTMDACC)for CA 125 blood tests annually or earlier if indicated
  6. 6) Willingness to return to UTMDACC 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 Physicians-Family Practice Associates Recruiting
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen H. Lu, MD         
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: April 30, 2014
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 October 29, 2014