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A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women | Clinical Trials | Clareo Health

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

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

NCT01121640•Fred Hutchinson Cancer Center

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. 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.

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.

Eligibility

Age

25 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+10 more criteria

Exclusion Criteria

•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.
•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.
+1 more criteria

Locations (5)

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

Key Dates

Start Date

November 1, 2009

Primary Completion Date

May 7, 2015

Completion Date

May 7, 2015

Last Updated

December 13, 2018

Enrollment

854

ACTUAL participants

Conditions

Epithelial Ovarian Cancer

Interventions

CA125 assay on Abbott Architect i1000SR platform

PROCEDURE

HE4 assay on Architect i1000SR platform

PROCEDURE

Transvaginal Ultrasound

PROCEDURE

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

NCT07432633

Colorectal CancerEpithelial Ovarian Cancer+3 more

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RECRUITINGPHASE1/PHASE2

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NCT05867251

Advanced Solid TumorHR+/HER2- Breast Cancer+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

Study of AVZO-021 in Patients With Advanced Solid Tumors

WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors

A Study of ZN-c3 in Patients With Ovarian Cancer

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