Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

Withdrawn

• Conditions: Pregnancy Related; Cancer; Gastro-Intestinal Disorder; Cardio-Respiratory Distress; Women's Health: Endometriosis; Autoimmune Diseases; Nephritis; Healthy; Neuro-Degenerative Disease
• Interventions: Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure

• Registration Number: NCT03884400
• Lead Sponsor: iSpecimen Inc

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.

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 Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2021-01-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who have provided consent for specimen collection	Specimens obtained from surgical, phlebotomy or other non-invasive procedure	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.

Primary Outcome Measures

Name	Time	Method
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use	15 years	The number of specimens and subjects distributed per disease will be measured and reported.

Trial Locations

Locations (1)

iSpecimen; 🇺🇸 Lexington, Massachusetts, United States