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Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

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ClinicalTrials.gov Identifier: NCT03884400
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
iSpecimen Inc

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer Pregnancy Related Gastro-Intestinal Disorder Cardio-Respiratory Distress Women's Health: Endometriosis Autoimmune Diseases Nephritis Healthy Neuro-Degenerative Disease Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure

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 Design
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Study Type : Observational
Estimated Enrollment : 1000000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : March 1, 2030
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diverse group of biorepositories with focus on cancer, neurodegenerative, pediatric, women's health and other cohorts.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884400


Contacts
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Contact: Emily Hubbard 2567970003 ehubbard@ispecimen.com
Contact: Jill Mullan 7813016688 jmullan@ispecimen.com

Locations
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United States, Massachusetts
iSpecimen
Lexington, Massachusetts, United States, 02420
Contact: Emily Hubbard    256-797-0003    ehubbard@ispecimen.com   
Sponsors and Collaborators
iSpecimen Inc
Investigators
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Principal Investigator: Chris Ianelli, MD, PhD iSpecimen Inc
More Information
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Additional Information:

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Responsible Party: iSpecimen Inc
ClinicalTrials.gov Identifier: NCT03884400    
Other Study ID Numbers: ISPC-180828-DISTRIBUTION
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Neurodegenerative Diseases
Endometriosis
Nephritis
 Autoimmune Diseases
Kidney Diseases
Urologic Diseases
Immune System Diseases
Nervous System Diseases