Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer (sncRNA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Susan Modesitt, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01187602
First received: August 22, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. For patients who have a diagnosis of ovarian Cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Identification of serum derived sncRNA biomarkers that correlate with disease burden in ovarian cancer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    In this aim pre- and post-remission samples from twenty women with stage III-IV ovarian cancer will be compared to twenty samples from control cancer-free subjects. Methods used will be essentially identical to those described above however, given the opportunity to use each patient as her own control and thus minimized confounders we believe deep sequencing of samples individually will provide better quality data and more robust statistical comparison.


Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 103
Study Start Date: August 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women at average risk for ovarian cancer
Women at average risk for ovarian cancer (no first degree relatives with breast or ovarian cancer) undergoing gynecologic evaluation at UVA for non-malignant or routine indications.
Women with ovarian cancer
Women with known or suspected ovarian cancer who are undergoing evaluation and/or treatment at UVA Cancer Center
Increased risk for ovarian cancer
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women in Gynecologic clinics

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187602

Contacts
Contact: Amir Jazaeri, MD 434-924-1570 aj2a@virginia.edu
Contact: Heather L Lothamer, MSN 434-924-9924 hll5y@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Heather Lothamer, MSN    434-924-9924    hll5y@virginia.edu   
Contact: Amir Jazaeri, MD    434-243-7208      
Principal Investigator: Amir Jazaeri, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Amir Jazaeri, MD University of Virginia
  More Information

No publications provided

Responsible Party: Susan Modesitt, MD, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01187602     History of Changes
Other Study ID Numbers: 15099
Study First Received: August 22, 2010
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Diseases
Disease Susceptibility
Ovarian Neoplasms
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 23, 2014