A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
NCT ID: NCT01121640
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
854 participants
INTERVENTIONAL
2009-11-30
2015-05-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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CA125 every screen, HE4 at confirmatory screen.
CA125 will be used at every screen. Women with a parametric empirical Bayes (PEB) longitudinal algorithm score above the 90th percentile will be asked to return for early recall screening. Women with a PEB score above the 95th percentile will be referred for confirmatory measurements of CA125 and HE4. If confirmatory test results are higher than expected, a transvaginal ultrasound will be performed.
CA125 assay on Abbott Architect i1000SR platform
Bead-based sandwich ELISA style assay
HE4 assay on Architect i1000SR platform
Bead-based sandwich ELISA style assay
Transvaginal Ultrasound
Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.
CA125 and HE4 at every screen.
CA125 and HE4 will both be used at every screen. Women with a PEB score above the 95th percentile on either CA125 or HE4 will be referred for confirmatory measurements of CA125 and HE4. If confirmatory test results are higher than expected, a transvaginal ultrasound will be performed.
CA125 assay on Abbott Architect i1000SR platform
Bead-based sandwich ELISA style assay
HE4 assay on Architect i1000SR platform
Bead-based sandwich ELISA style assay
Transvaginal Ultrasound
Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.
Interventions
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CA125 assay on Abbott Architect i1000SR platform
Bead-based sandwich ELISA style assay
HE4 assay on Architect i1000SR platform
Bead-based sandwich ELISA style assay
Transvaginal Ultrasound
Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject has tested positive for a deleterious germ line mutation in BRCA1 or BRCA2.
Risk Group 2, Women ages 35 - 80, Pedigree conditions can be satisfied by multiple primary cancers in the same person:
* The subject has a personal history of breast cancer diagnosed before or at age 50.
* OR the subject has a personal history of bilateral breast cancer
* OR the subject has one first-degree relative with breast cancer diagnosed before or at age 50.
* OR the subject has two breast cancers in the first or second degree relatives, same lineage, with at least one breast cancer diagnosed before or at age 50.
* OR the subject has three or more first or second degree relatives, same lineage, with breast cancer diagnosed at any age.
* OR The family contains at least one ovarian cancer diagnosed at any age in the first or second degree relatives.
* OR the subject is of Ashkenazi ancestry and has had breast cancer diagnosed at any age.
* OR The subject is of Ashkenazi Jewish ethnicity and has one first or second degree relative with breast cancer diagnosed at any age (must be in the same lineage as the Ashkenazi ancestry)
* OR The subject has a male relative with breast cancer diagnosed at any age
* OR The subject has a personal history of a positive genetic test result for a deleterious germline mutation in the P53 gene.
* OR The subject has tested positive for a deleterious germline mutation in one of the DNA mismatch repair (MMR) genes associated with the Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC, also known as Lynch Syndrome) The MMR genes include MLH1, MSH2, MSH6 and PMS2.
* OR the subject has a first or second degree relative with an identified deleterious germline BRCA1 or BRCA2 mutation, but has not yet undergone testing herself.
* OR the subject has a first or second degree relative with an identified deleterious germline MMR gene mutation, but has not yet undergone testing herself.
* OR Probability of carrying a BRCA1 or BRCA2 mutation given family pedigree of breast and ovarian cancers exceeds 20% by any existing BRCA mutational probability model.
Risk Group 3, Women ages 45 - 80:
* Have measurement of CA125, HE4, MMP7 or Mesothelin exceeding the 95th percentile;
* OR have a relative risk of at least 2 based on the EpiRisk logistic regression model including age, family history, and other risk factors.
Exclusion Criteria
* History of ovarian, fallopian tube cancer or peritoneal carcinomatosis.
* Currently pregnant.
* Unable or unwilling to provide informed consent.
* Unwilling to provide the name of a physician.
* Unwilling to sign informed consent and/or medical records release form.
* Current untreated malignancy (other than non-melanoma skin cancer).
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer (except tamoxifen or aromatase inhibitors +/- lupron). Patients who are being treated may enroll 3 months after completion of last treatment.
* Intraperitoneal surgery within the last 3 months (laparoscopy or laparotomy).
* A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia.
* Subject has a family member who is a carrier of a BRCA or MMR gene mutation and the subject has undergone genetic testing that included the family mutation and no mutation was found, and there are no cases of ovarian cancer in the family.
25 Years
80 Years
FEMALE
No
Sponsors
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The Marsha Rivkin Center for Ovarian Cancer Research
OTHER
Canary Foundation
OTHER
Swedish Medical Center
OTHER
City of Hope Medical Center
OTHER
Cedars-Sinai Medical Center
OTHER
Stanford University
OTHER
Fox Chase Cancer Center
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nicole Urban, ScD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Beth Karlan, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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City of Hope
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Anderson GL, McIntosh M, Wu L, Barnett M, Goodman G, Thorpe JD, Bergan L, Thornquist MD, Scholler N, Kim N, O'Briant K, Drescher C, Urban N. Assessing lead time of selected ovarian cancer biomarkers: a nested case-control study. J Natl Cancer Inst. 2010 Jan 6;102(1):26-38. doi: 10.1093/jnci/djp438. Epub 2009 Dec 30.
Lowe KA, Andersen MR, Urban N, Paley P, Dresher CW, Goff BA. The temporal stability of the Symptom Index among women at high-risk for ovarian cancer. Gynecol Oncol. 2009 Aug;114(2):225-30. doi: 10.1016/j.ygyno.2009.03.015. Epub 2009 May 7.
Andersen MR, Karlan BY, Drescher CW, Paley P, Hawley S, Palomares M, Daly MB, Urban N. False-positive screening events and worry influence decisions about surgery among high-risk women. Health Psychol. 2019 Jan;38(1):43-52. doi: 10.1037/hea0000647. Epub 2018 Nov 15.
Andersen MR, Goff BA, Lowe KA, Scholler N, Bergan L, Drescher CW, Paley P, Urban N. Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol. 2010 Mar;116(3):378-83. doi: 10.1016/j.ygyno.2009.10.087. Epub 2009 Nov 28.
Related Links
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homepage of the Pacific Ovarian Cancer Research Consortium
Other Identifiers
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6973
Identifier Type: OTHER
Identifier Source: secondary_id