Protocols Development for Single Cells Genomics and Their Implementation for Molecular Diversity Between Cells

September 1, 2015 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

Adults

Exclusion Criteria:

  • Non

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring single-cell variability using single-cell genomics
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 16, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 123456- HMO-CTIL

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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