Ovarian CancerNCT00539162
Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
A study testing Questionnaire in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 12 sites in United States.
Trial summary
The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,000 participants
- Where
- 12 sitesUnited States
- Study dates
- 2 Jul 2001to 30 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, >/= 50 years old or less than 75 years old.
- Postmenopausal (>/= 12 months amenorrhea).
- Have at least one ovary.
- Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.
- Willingness to return for CA 125 blood tests annually or earlier if indicated.
- Willingness to return to undergo transvaginal ultrasound if indicated.
- Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated
Who cannot join
- Female: Less than 50 years old or older than 75 years at the time of enrollment.
- Psychiatric or psychological or other conditions which prevent a fully informed consent.
- Prior removal of both ovaries.
- Active non-ovarian malignancy.
- 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.
- 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.)
- Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Coordinator MD Anderson contact
12 sites in 1 country
United States12 sites, 10 recruiting
- Active, not recruiting
The University of Texas at Austin
Austin, Texas, 78712
- Active, not recruiting
University of Texas (UT) Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
John Stoddard Cancer Center
Des Moines, Iowa, 50309
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Denise H. Nebgen, MD, PHD, MD, PHD
- Recruiting
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
Houston, Texas, 77054
- Recruiting
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
Miami, Florida, 33136
Brian Slomovitz, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Samantha Hoffman, MD
- Recruiting
Carol G. Simon Cancer Center / Atlantic Health
Morristown, New Jersey, 07962
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Laura Holman, MD
- Recruiting
Women's and Infant's Hospital
Providence, Rhode Island, 02905
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Richard Moore, MD
- Recruiting
UT Health Science Center San Antonio
San Antonio, Texas, 78229
Georgia McCann, MD
About this study
The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.
Read the detailed description
Up to 8,000 women will take part in this multicenter study.
Currently, there is no effective screening to detect ovarian cancer at its earliest stage in low risk women. CA-125 is an FDA approved blood test that may show the presence of ovarian cancer. Researchers have found other blood tests that detect ovarian cancers that may be missed by CA125 testing. Results of blood tests are combined into a Risk of Ovarian Cancer-2 (ROCA2) score to decide whether you need to return for additional bloodwork and/or an ultrasound.
If you are eligible to take part in this research study:
You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers that can detect ovarian cancer.
You will be asked to complete a questionnaire about your medical and family history. It should take about 20-30 minutes to complete.
You will be asked to complete a questionnaire about your symptoms. It should take about 10-15 minutes to complete.
Depending on your CA-125 level you will receive 1 of 3 recommendations:
You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 1 year.
You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 3 months, OR You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers, and you will have a transvaginal ultrasound (to look at your ovaries and fallopian tubes) in 6 weeks +/- 2 weeks.
An ultrasound test uses sound waves to check the position, size, and shape of the ovaries. During a transvaginal ultrasound, a small probe will be placed in your vagina and used to create and measure sound waves.
Based on the results of the transvaginal ultrasound (if you receive one):
You and the study doctor will discuss options for further treatment or standard cancer management, OR You will have blood (about 3-4 tablespoons) drawn for testing of tumor markers in 3 months.
When you return for your next yearly visit:
You will be asked to complete the questionnaire about your symptoms. You will be asked to complete a follow-up visit survey so that any updates to your personal and family medical history can be recorded. It should take about 10 minutes to complete.
Your blood draw results will be sent to you by letter or e-mail so that you will know when to return for a visit.
If you miss a visit, the study staff may try to contact you by telephone, e-mail, or letter. Visit reminders may also be sent to you by letter or e-mail.
If you are unable to return for visits after 3 years, you will be taken off study. You may continue to take part in this study unless you no longer qualify for the study or you no longer would like to take part in this study.
If you develop ovarian or non-ovarian cancer on this study, researchers will no longer collect blood draws, transvaginal ultrasounds, or questionnaires from you. However, the study team will continue to collect updates in your medical record. This includes slides that will be reviewed from cases of ovarian or non-ovarian cancer that are collected as part of your standard of care.
- Conditions
- Ovarian Cancer
- Being tested
- Questionnaire
- Keywords
- Ovarian Cancer, CA 125 Algorithm, Cancer Detection, Questionnaire, Survey
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires completed at baseline and during each follow up visit.
| Study group | Role | What they receive |
|---|---|---|
| CA 125 Analysis | Experimental | Experimental: CA-125 Analysis
Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers.
Depending on CA-125 level and other tumor markers:
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR
Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of increase in CA 125 levels and other tumor markers over time
[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.]
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study start2 Jul 2001
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Golfers Against Cancer
- Responsible party
- Sponsor
- Investigators
- Denise Nebgen, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539162
- Sponsor's protocol ID
- ID01-022
- Other IDs
- RP160145, U01CA200462, P50CA083639, NCI-2018-02168
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2007
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han CY, Lu KH, Corrigan G, Perez A, Kohring SD, Celestino J, Bedi D, Bedia E, Bevers T, Boruta D, Carlson M, Holman L, Leeds L, Mathews C, McCann G, Moore RG, Schlumbrecht M, Slomovitz B, Tobias D, Williams-Brown Y, Bevers MW, Liu J, Gornet TG, Handy BC, Lu Z, Bedia JS, Skates SJ, Bast RC Jr. Normal Risk Ovarian Screening Study: 21-Year Update. J Clin Oncol. 2024 Apr 1;42(10):1102-1109. doi: 10.1200/JCO.23.00141. Epub 2024 Jan 9.
PubMed 38194613