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

Description

The goal of this clinical research study is to evaluate a method involving 4 blood tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that may be helpful in the early detection of ovarian cancer in women who are at low risk.

Conditions

Ovarian Cancer

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Study Overview

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Study Details

Study overview

The goal of this clinical research study is to evaluate a method involving 4 blood tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that may be helpful in the early detection of ovarian cancer in women who are at low risk.

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

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine, Miami, Florida, United States, 33136

Des Moines

John Stoddard Cancer Center, Des Moines, Iowa, United States, 50309

Morristown

Carol G. Simon Cancer Center / Atlantic Health, Morristown, New Jersey, United States, 07962

Rochester

University of Rochester Medical Center, Rochester, New York, United States, 14642

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Providence

Women's and Infant's Hospital, Providence, Rhode Island, United States, 02905

Austin

The University of Texas at Austin, Austin, Texas, United States, 78712

Dallas

University of Texas (UT) Southwestern Medical Center, Dallas, Texas, United States, 75390

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Houston

Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA), Houston, Texas, United States, 77054

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

50 Years to 74 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

M.D. Anderson Cancer Center,

Denise Nebgen, MD, PHD, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center

Study Record Dates

2028-11-30