Short Non-coding RNA Biomarkers of Predisposition to Ovarian Cancer

NCT01187602 | Unknown DMC

• 1 other identifier: 15099
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Defining sncRNA alterations associated with hereditary predisposition to ovarian cancer

  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.

  24 months

• Identification of serum derived sncRNA biomarkers that correlate with disease burden in ovarian cancer.

  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.

  24 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women in Gynecologic clinics

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Susan Modesitt, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Modesitt, MD

CONTACT

434-924-5197; scm6h@virginia.edu

Heather L Lothamer, MSN

CONTACT

434-924-9924; hll5y@virginia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 22, 2010
• First Posted: August 24, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)