NCT02540941

Brief Summary

The investigators will extract single cells and analyze the molecular composition of single cells as well as bulks using the latest protocols for single cell and bulk genomics analyses including genetic, epigenetic, transcriptomic and proteomic analyses using the latest available protocols. A broad list of such example protocols are listed below. The samples and their molecular characterization (including sequencing \& molecular levels) will serve as the basis for development of methods for single cells analysis. The developed methods are aimed at genomic transcriptomic, epigenetic, or proteomics analysis of single cells and share the same structure: the measured feature will be translated to a DNA library which will represent the feature by a dedicated assay. This library alongside with proper mathematical analysis of the sequencing results will be performed in order to conclude the desired feature. The general structure of such protocols is described in our review paper (Single-cell sequencing-based technologies will revolutionize whole-organism science, E. Shapiro, T. Biezuner \& S.Linnarsson, Nature Reviews Genetics 14, 618-630, 2013) which is attached to our proposal. In addition, the researchers will use sequencing based methods (existing and future developed) in order to compare single cells and bulks from different tissues and/or different time points from the same donor in order to measure genetic, epigenetic, transcriptomic, and proteomic diversity.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Last Updated

September 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

June 16, 2015

Last Update Submit

September 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measuring single-cell variability using single-cell genomics

    Individual cells samples from multiple tissues, possibly at multiple time points, will be characterized using advanced single-cell genomics protocols. The genomic, transcriptomic and epigenomic signatures of the cells will be measured. Genomic signatures will be used to establish lineage relations among cells. Transcriptomic and epigenomic signatures will be used to characterize cell type and functional state. Statistical analysis will be performed to characterize cell type and state variability and its correlation with lineage relations, tissue of origin and donor age. Bulk samples will be analyzed as controls, as well as for comparing the information gleaned from single-cell analysis to that obtained solely by bulk analysis.

    5 years

Interventions

nonOTHER

Eligibility Criteria

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

We will obtain human single and bulk cells from healthy donors. Volunteers will be sperm donors who shall designate part or full donation to the proposed research. Egg donors who shall designate part of the eggs to the proposed research; for women who come to the clinics of fertility problems. Reaching the donors will be using advertisements in sperm banks and in women's health centers or asking for student volunteers.

You may qualify if:

  • Adults

You may not qualify if:

  • Non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

September 4, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2018

Last Updated

September 4, 2015

Record last verified: 2015-06