Collection and Distribution of Biospecimens for Novel Research

Healthy Clinical Trial

Official title:

iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05080907
• Other study ID #: ISPC-160630-REM/RUO/
• Status: Enrolling by invitation
• Start date: July 15, 2016
• Est. completion date: January 2025

Study information

• Verified date: November 2022
• Source: iSpecimen Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

iSpecimen aims to create a clinical partner network of hospitals, laboratories, academic institutions, and other healthcare organizations ("institutions") capable of providing researchers and educators ("researchers") with annotated biospecimens for use in biomarker discovery and validation; diagnostic test and instrumentation development and validation; therapeutics development; other medical research including the impact that various specimen collection and handling methods and conditions have on research results; and in education such as researcher or physician training (collectively "research").

Description:

The level of involvement for each network institution will vary based on the type of specimen to which they have access (e.g. biofluids, tissues and/or cells) and the category of collection (remnant specimens that were originally collected for clinical testing and/or specimens specifically collected for research) in accordance with the institution's elected preferences.

In most cases, potential participants will be identified and approached upon presenting for clinical care or recruited specifically for the study using outreach programs. If additional screening activities are required to determine eligibility criteria, the potential participant may be presented with the opportunity to participate in these activities as part of the study. These screening activities will be minimal risk in nature and are described further below. Should potential participants meet screening criteria, they may then be asked to provide biospecimens according to current research needs. Individual participants or groups of participants may be sought according to specific clinical, lifestyle, and/or demographic characteristics. The providers of these samples may be healthy participants or participants with a medical condition of interest to the research community but regardless, all specimens collected under this protocol (whether for screening purposes and for distribution to researchers) will qualify as minimal risk activities.

Biospecimens may be distributed to researchers at academic institutions, hospitals, clinical and government laboratories, and corporations including diagnostic, medical device, biopharmaceutical and biotechnology companies. The types of research studies and testing that may be performed using the biospecimens will be varied, and it is not possible to provide a description of all potential studies. Some researchers may perform genetic testing on the specimens, some may use the specimens to develop cell lines, and some may cryopreserve the specimens for many years, awaiting a research use. The specimens may also be used for educational purposes, such as training lab techs on the proper testing of samples or physicians on the proper reading of stained slides. The iSpecimen consent forms will indicate a broad scope of possible research and educational uses and activities.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

Inclusion Criteria:

• Individual is developmentally aged 7 years old and above for RUO collections (only)

• Individual meets requirements of a current request for research materials from iSpecimen

• If a blood collection will be performed as part of the screening process or RUO collection, the individual's health will be assessed by medical staff through medical record review, clinical exam, and/or the review of an updated medical history as provided by the participant

• Individual has reviewed and signed a consent form for an RUO specimen collection if required as part of the research or if a minor or a person with diminished decision-making capacity, their parent/guardian or Legally Authorized - Representative has reviewed and signed the consent form on their behalf.

• Individual has reviewed and signed a consent form for remnant specimen usage in research if required as part of the research or if a minor or a person with diminished decision-making capacity, their parent/guardian or Legally Authorized Representative has reviewed and signed the consent form on their behalf

Exclusion Criteria:

• Subjects that do not meet the inclusion criteria outlined above.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Blood Disease
• Cancer
• Communicable Diseases
• Dermatologic Disease
• Gastrointestinal Complication
• Healthy
• Hematologic Diseases
• Infections
• Infectious Disease
• Skin Diseases
• Women's Health: High-Risk Pregnancy

Intervention

Other:
• Observational
Subjects for observational study Various conditions & healthy subjects

Locations

Country	Name	City	State
United States	Central Alabama	Birmingham	Alabama
United States	Western New York	Buffalo	New York
United States	Northern Alabama	Huntsville	Alabama
United States	Southern Alabama Area	Mobile	Alabama
United States	Central Alabama	Montgomery	Alabama
United States	Greater Philadelphia Area	Philadelphia	Pennsylvania
United States	Western Pennsylvania	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
iSpecimen Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Biospecimens for Novel Research Uses	Repository of diseased and healthy tissue, blood derivatives and related biological specimens	10 years
Secondary	Number of subjects enrolled	Each subject will have contributed at least one biospecimen	10 years

External Links

•   iSpecimen was founded to address a critical challenge: how to connect life science researchers who need human biospecimens with the billions of specimens available in healthcare organizations worldwide.