Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer (sncRNA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01187602|
Recruitment Status : Unknown
Verified December 2014 by Susan Modesitt, MD, University of Virginia.
Recruitment status was: Recruiting
First Posted : August 24, 2010
Last Update Posted : December 5, 2014
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||103 participants|
|Observational Model:||Case Control|
|Official Title:||A Pilot Study of Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
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.
- Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer [ Time Frame: 24 months ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187602
|Contact: Susan Modesitt, MDfirstname.lastname@example.org|
|Contact: Heather L Lothamer, MSNemail@example.com|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Heather Lothamer, MSN 434-924-9924 firstname.lastname@example.org|
|Contact: Susan Modesitt, MD 434-243-5197|
|Principal Investigator: Susan Modesitt, MD|
|Principal Investigator:||Susan Modesitt, MD||University of Virginia|