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Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00539162
Recruitment Status : Recruiting
First Posted : October 4, 2007
Last Update Posted : September 15, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Golfers Against Cancer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
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 women who are at low risk.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Questionnaire Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
Actual Study Start Date : July 2, 2001
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: CA 125 Analysis

Participants will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers.

Depending on CA-125 level:

Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.

Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.

Questionnaires completed at baseline and during each follow up visit.

 Behavioral: Questionnaire
Questionnaires completed at baseline and during each follow up visit.
Other Name: Survey


Outcome Measures
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Primary Outcome Measures :
  1. Rate of increase in CA 125 levels over time [ Time Frame: Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 for CA 125 blood tests annually or earlier if indicated.
  6. Willingness to return 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 at the time of enrollment.
  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 SERMS (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 due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal & one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. 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. d. 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.)
  7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539162


Contacts
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Contact: Gwen H. Corrigan 713-563-1790 gcorriga@mdanderson.org
Contact: Study Coordinator MD Anderson 713-563-6728

Locations
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United States, Florida
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Brian Slomovitz, MD         
United States, Iowa
John Stoddard Cancer Center Recruiting
Des Moines, Iowa, United States, 50309
United States, New Jersey
Carol G. Simon Cancer Center / Atlantic Health Recruiting
Morristown, New Jersey, United States, 07962
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Richard Moore, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Laura Holman, MD         
United States, Rhode Island
Women's and Infant's Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, Texas
The University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Marian Williams-Brown, MD         
University of Texas (UT) Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Karen H. Lu, MD         
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA) Recruiting
Houston, Texas, United States, 77054
UT Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Georgia McCann, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Golfers Against Cancer
Investigators
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Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539162    
Other Study ID Numbers: ID01-022
RP160145 ( Other Grant/Funding Number: CPRIT )
U01CA200462 ( U.S. NIH Grant/Contract )
P50CA083639 ( U.S. NIH Grant/Contract )
NCI-2018-02168 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 4, 2007    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
CA 125 Algorithm
Cancer Detection
Questionnaire
Survey
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type