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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539162
First received: October 3, 2007
Last updated: April 13, 2017
Last verified: April 2017
  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 women who are at low risk.

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) ]

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: 8000
Actual Study Start Date: July 2, 2001
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 1, 2018 (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 complete questionnaires.
Behavioral: Questionnaire
Completed during follow up visits.
Other Name: Survey

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes 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 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
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: Gwen H. Corrigan 713-563-1790
Contact: Study Coordinator MD Anderson 713-563-6728

Locations
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, Rhode Island
Women's and Infant's Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, Texas
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
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00539162     History of Changes
Other Study ID Numbers: ID01-022
RP160145 ( Other Grant/Funding Number: CPRIT )
U01CA200462 ( U.S. NIH Grant/Contract )
P50CA083639 ( U.S. NIH Grant/Contract )
Study First Received: October 3, 2007
Last Updated: April 13, 2017

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

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

ClinicalTrials.gov processed this record on July 19, 2017