NCT03884400

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

5 years

First QC Date

March 18, 2019

Last Update Submit

November 8, 2022

Conditions

Keywords

Observational

Outcome Measures

Primary Outcomes (1)

  • Distribution of Biospecimens From Biorepositories/Biobanks for Research Use

    The number of specimens and subjects distributed per disease will be measured and reported.

    15 years

Study Arms (1)

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

Interventions

Biospecimen Collection

Subjects who have provided consent for specimen collection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iSpecimen

Lexington, Massachusetts, 02420, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsDigestive System DiseasesAutoimmune DiseasesNephritis

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Immune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 21, 2019

Study Start

January 1, 2021

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations