NCT02864329

Brief Summary

Basic and clinical research is revealing that various noncoding and small RNAs play important and diverse roles in germ cell development and quality, including X/Y silencing during meiosis, gene regulation, DNA damage responses, and protection of the genome against transposable elements. Indeed, mammalian germ cells are known to harbor multiple small RNA species, including small interfering RNAs (siRNA), microRNAs (miRNA), and germline- specific PIWI- interacting RNAs (piRNA). However, their mechanistic roles in gametogenesis and human infertility are largely uncharacterized. The goal of this study is to elucidate the role of small RNA pathways in the events that give rise to viable euploid gametes. Four projects and three cores are included in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

10 years

First QC Date

April 26, 2016

Last Update Submit

July 17, 2024

Conditions

Keywords

Male Infertilitymicro RNAssmall interfering RNAsmiRNAsiRNA

Outcome Measures

Primary Outcomes (1)

  • Using RNA from men with normal spermatogenesis and men with infertility for multiplexed deep sequencing to identify differentially expressed miRNAs

    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.

    5 years

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men between the age of 18 and 90 who have testicular cancer and underwent surgery for removal at Weill Cornell Medicine.

You may qualify if:

  • Men between the ages of 18-90 who have testicular cancer and underwent surgery at Weill Cornell Medicine.

You may not qualify if:

  • Women, men outside of the age parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Testicular tissue, penile tissue

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Peter N Schlegel, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Paula E. Cohen, Ph.D.

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

August 12, 2016

Study Start

April 1, 2014

Primary Completion

March 20, 2024

Study Completion

March 20, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations