Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

Sponsor

iSpecimen Inc (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03884400

Collaborator

(none)

1,000,000

Enrollment

Location

61.9

Anticipated Duration (Months)

16147.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

1000000 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.