Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

November 8, 2022 updated by: iSpecimen Inc

iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.

Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.

This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.

Study Type

Observational

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Lexington, Massachusetts, United States, 02420
        • iSpecimen

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diverse group of biorepositories with focus on cancer, neurodegenerative, pediatric, women's health and other cohorts.

Description

Inclusion Criteria:

  • Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed.
  • Specimens from biobanks that have collected materials and de-identified data under a waiver of consent
  • Specimens from a biobank that meet the criteria for non human subject research under the common rule.

Exclusion Criteria:

  • Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.

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?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who have provided consent for specimen collection
Re-consent will not be required. This protocol allows distribution of the specimens following the terms agreed to by the subject in the original consent.
Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure
Biospecimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
Time Frame: 15 years
The number of specimens and subjects distributed per disease will be measured and reported.
15 years

Collaborators and Investigators

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

Sponsor

iSpecimen Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2025

Study Completion (ANTICIPATED)

March 1, 2026

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (ACTUAL)

March 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISPC-180828-DISTRIBUTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Autoimmune Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe