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A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

18 Years
90 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

Epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because
80% of tumors have metastasized beyond the ovary at the time of diagnosis. Screening efforts
aimed at improved identification of early stage disease have been largely unsuccessful,
because of ovarian cancer's propensity for early spread. Our hypothesis is that this
obstacle can be circumvented by identifying biomarkers for the precancerous stage of this
disease. Since this pre-cancerous stage is currently undetectable, we instead propose to
look for biomarkers in women at very high risk for developing ovarian cancer due to genetic
mutations. We hypothesize that identification of markers for genetic predisposition to
ovarian cancer will also be informative for detection of biological changes that over time
lead to sporadic cancers. Given their increasingly recognized role in states of normal and
abnormal growth and differentiation, we hypothesize that short non-coding RNAs (sncRNAs)
hold significant promise as biomarkers of ovarian cancer predisposition. We will test these
hypotheses in two aims. First, we will identify biomarkers for hereditary ovarian cancer
risk by comparing serum-derived sncRNAs in women with and without hereditary risk for
ovarian cancer. In the second aim we will define serum-derived sncRNAs correlates of ovarian
cancer disease status. We will compare sera from ovarian cancer patients at times of highest
and lowest disease burden to those of control, cancer-free subjects. Each aim will provide
independent, novel, and important information for future investigations. The sncRNAs found
to be differentially expressed in both aims will be prioritized for future validation in
women under clinical surveillance for hereditary risk of ovarian cancer.

Inclusion Criteria:

- Undergoing medical care at UVA

- Up to date breast cancer screening

- Subjects must fall into one of the following groups:

- Women at increased risk of ovarian cancer based on family history, personal
history, or genetic factors defined as either BRCA1 or BRCA2 mutations who still
retain both fallopian tubes and both ovaries.

- Women at average risk for ovarian cancer

- Women with known/suspected or recurrent ovarian cancer who are undergoing
evaluation and/or treatment at UVA Cancer Center

Exclusion Criteria:

- Subjects with increased risk for ovarian cancer may not have a history of prior
malignancy within the last 10 years excluding cervical carcinoma in situ or basal
cell carcinoma

- Pregnancy (self reported)

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer

Outcome Description:

Serum samples will be collected from patients with known BRCA mutations. As a control, we will recruit age-matched women undergoing gynecologic evaluation for benign disease without any personal or family history of cancer. The normal and BRCA mutation groups will be pooled for deep sequencing. Pooled sample short RNAs will be cloned and subjected to deep sequencing and bioinformatic analysis. Validation of 5-10 differentially expressed sncRNAs is performed by quantitative RT-PCR and Northern blots on individual control and high risk samples.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Amir Jazaeri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

June 2014

Related Keywords:

  • Ovarian Cancer
  • Disease Susceptibility
  • Ovarian Neoplasms



University of Virginia Charlottesville, Virginia  22908