RECRUITING

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

Conditions

Ovarian Cancer CA 125 Algorithm Cancer Detection Questionnaire Survey

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2001-07-02

Study Completion:2028-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00539162

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.

Ages Eligible for Study:50 Years to 74 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Gwen H. Corrigan

CONTACT

713-563-1790

gcorriga@mdanderson.org

Study Coordinator MD Anderson

CONTACT

713-563-6728

Principal Investigator

Denise Nebgen, MD, PHD

PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Study Locations (Sites)

Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine

Miami, Florida, 33136

United States

John Stoddard Cancer Center

Des Moines, Iowa, 50309

United States

Carol G. Simon Cancer Center / Atlantic Health

Morristown, New Jersey, 07962

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Women's and Infant's Hospital

Providence, Rhode Island, 02905

United States

The University of Texas at Austin

Austin, Texas, 78712

United States

University of Texas (UT) Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)

Houston, Texas, 77054

United States

UT Health Science Center San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2001-07-02

Study Completion Date2028-11-30

Study Record Updates

Study Start Date2001-07-02

Study Completion Date2028-11-30

Terms related to this study

Keywords Provided by Researchers

Ovarian Cancer
CA 125 Algorithm
Cancer Detection
Questionnaire
Survey

Additional Relevant MeSH Terms

Ovarian Cancer