- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02864329
Small RNA Pathways in Mammalian Gametogenesis
Study Overview
Status
Conditions
Detailed Description
Project 2 (PI: Dr. Darius Paduch): Role of Small RNAs in male infertility. The leading hypothesis of this project is based on extensive preliminary results obtained by this group showing that 70% of miRNA expressed from human testis are highly conserved in humans and rodents. The investigators hypothesize that differentially expressed miRNAs in men with infertility lead to changes in levels of target messenger RNAs (mRNAs) involved in key regulatory pathways in cell biology. The results of this project will lead to better understanding of miRNAs' role in male reproduction and have strong potential to enable the development of new miRNA-based or miRNA-regulating therapies. This project will help to develop new transgenic animals to study miRNA in vivo with implications not only for infertility, but also biology of testicular cancer. Derived RNA based therapies have the potential to be less invasive, less toxic, and more effective in treating these serious and increasingly prevalent conditions.
Core A (PI: Dr. Paula E. Cohen): Administration Core. The main objective of the Administrative Core (Core A) is to provide a structure and support mechanism to the entire Center for Reproductive Genomics (CRG). The Admin core will facilitate interactions across the Ithaca and Manhattan campuses of Cornell University, will encourage research in small RNA biology, both in reproductive medicine and across clinical disciplines, and will promote strong training in reproductive medicine that encourages a translational focus. In general, the Admin core will focus efforts on three major philosophies: translational and innovative research, teaching, and outreach.
Core B (PI: Dr. Andrew Grimson): RNA Sequencing Core. The main objective of the RNA Sequencing Core (RSC) is to provide users with efficient and high quality access to cutting-edge sequencing technologies. These sequencing technologies will be used by all members of this P50-proposal, and made available to other P50-centers. Importantly, all members of this P50 are relying on access to these technologies to achieve their project goals. By centralizing sequencing at the RSC, sequencing will be performed at a lower cost and with greater efficiency that would be possible for individual users.
Core C (PI: Dr. Peter Schlegel): Outreach Core The goals of this outreach core are two-fold: (1) to provide a scientific and technical resource for clinicians interested in embarking on research involving small RNA biology in their physiological system of interest, and (2) to provide outreach to the community by means of a state- of-the-art lecture series. The Innovation Seminars in Reproductive Technologies Series (InSeRT), in order to educate patients about the latest advances in our understanding of the genetic and epigenetic basis for human disease.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lauren H Chen
- Phone Number: 2127465706
- Email: luc2013@med.cornell.edu
Study Locations
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New York
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New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine
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Contact:
- Lauren Chen
- Phone Number: 212-746-5706
- Email: luc2013@med.cornell.edu
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Principal Investigator:
- Darius A Paduch, M.D., Ph.D.
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Sub-Investigator:
- Peter N Schlegel, M.D.
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Sub-Investigator:
- Paula E Cohen, Ph.D.
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Sub-Investigator:
- Andrew Grimson, Ph.D.
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Sub-Investigator:
- John Schimenti, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men between the ages of 18-90 who have testicular cancer and underwent surgery at Weill Cornell Medicine.
Exclusion Criteria:
- Women, men outside of the age parameters
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Using RNA from men with normal spermatogenesis and men with infertility for multiplexed deep sequencing to identify differentially expressed miRNAs
Time Frame: 5 years
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Detect target mRNAs through correlation analysis of actual mRNA expression profiles obtained from the same patients.
At the end of the proposed funding period, project 2 will have identified and confirmed a set of approximately 20-30 miRNA:mRNA interactions in male infertility.
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5 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Darius A Paduch, M.D., Ph.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1209013034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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