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Epithelial Ovarian CancerNCT01121640

A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women

A study testing CA125 assay on Abbott Architect i1000SR platform, HE4 assay on Architect i1000SR platform and Transvaginal Ultrasound in people with Epithelial Ovarian Cancer, run by Fred Hutchinson Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. Read more about this study

Who is it for?
Ages 25 to 80 years, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
CA125 assay on Abbott Architect i1000SR platform, HE4 assay on Architect i1000SR platform and Transvaginal Ultrasound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
854 participants
Where
5 sitesUnited States
Study dates
Nov 2009to 7 May 2015
Phase
Interventional
Are there results?
None posted in the registry

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 25 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Risk Group 1, Women ages 25 - 80:
  • 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.
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  • 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.

Who cannot join

  • Removal of both ovaries for any reason.
  • 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.
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • City of Hope

    Duarte, California, 91010

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women

The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.

Read the detailed description

Epithelial ovarian cancer (EOC) is usually lethal unless it is diagnosed at an early stage, thus early detection is likely to play an important role in reducing its mortality. Within the Ovarian Specialized Programs of Research Excellence Pacific Ovarian Cancer Research Consortium (POCRC) researchers have been working for a decade to discover, develop, and validate biomarkers (proteins or substances found in blood) that could help save lives by detecting EOC early. During the last five years several biomarkers, including CA125, have been evaluated for their ability to detect EOC at an earlier stage. The best markers will now be studied in a new randomized controlled trial of ovarian cancer screening.

Being tested
CA125 assay on Abbott Architect i1000SR platform, HE4 assay on Architect i1000SR platform, Transvaginal Ultrasound
Keywords
Ovarian Cancer, Screening, Biomarkers
Medical subject headings
Carcinoma, Ovarian Epithelial, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CA125 assay on Abbott Architect i1000SR platformProcedure or surgery

    Also called Abbott Architect CA125 assay

    Bead-based sandwich ELISA style assay

  • HE4 assay on Architect i1000SR platformProcedure or surgery

    Also called Abbott Architect HE4 assay

    Bead-based sandwich ELISA style assay

  • Transvaginal UltrasoundProcedure or surgery

    Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.

Study groups in NCT01121640
Study groupRoleWhat they receive
CA125 every screen, HE4 at confirmatory screen.OtherCA125 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.
Receives: Procedure: CA125 assay on Abbott Architect i1000SR platform; Procedure: HE4 assay on Architect i1000SR platform; Procedure: Transvaginal Ultrasound
CA125 and HE4 at every screen.OtherCA125 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.
Receives: Procedure: CA125 assay on Abbott Architect i1000SR platform; Procedure: HE4 assay on Architect i1000SR platform; Procedure: Transvaginal Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive predictive value of each of the two screening protocols

    Calculated as number of women with a significant lesion identified at a protocol-indicated procedure divided by number of women with protocol-indicated surgical procedures performed.

    Measured: From first screen through remaining study period

Secondary outcomes (2)

  1. Screening compliance

    Calculated as number of screens performed within 3 months of date scheduled divided by number of screens scheduled.

    Measured: From first screen through remaining study period

  2. Cancer related distress and health related quality of life

    Assessed using the SF-36 scale assessing HRQOL and versions of the Impact of Events Scale assessing distress associated with worry about cancer risk, and the Cancer Worry Scale

    Measured: At baseline, each screen, 6 weeks post-surgery to remove remaining ovary/ies, and 6 months after post-surgical assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2010 (estimated)
  2. Study startNov 2009
  3. Primary completion7 May 2015
  4. Study completion7 May 2015

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
854 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01121640
Sponsor's protocol ID
P50CA083636-01
Other IDs
6973
Status last verified
Dec 2018
First submitted
10 May 2010
Last updated
13 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19945742

  • 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.

    PubMed 20042715

  • 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.

    PubMed 19427026

  • 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.

    PubMed 30431292

Questions about this trial

What is this clinical trial studying?

A study testing CA125 assay on Abbott Architect i1000SR platform, HE4 assay on Architect i1000SR platform and Transvaginal Ultrasound in people with Epithelial Ovarian Cancer, run by Fred Hutchinson Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive predictive value of each of the two screening protocols (time frame: From first screen through remaining study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01121640, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.

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