Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

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 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

HE4 assay on Architect i1000SR platform

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

Transvaginal Ultrasound

Nicole Urban, ScD

Beth Karlan, MD

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.

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.

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

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.

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women	NCT01121640	Epithelial Ovar...	CA125 assay on ... HE4 assay on Ar... Transvaginal Ul...	25 Years - 80 Years	Fred Hutchinson Cancer Center
A Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women	NCT01121640	Epithelial Ovar...	CA125 assay on ... HE4 assay on Ar... Transvaginal Ul...	25 Years - 80 Years	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for ca125 assay on abbott architect i1000sr platform