Healthy Clinical Trial
Official title:
iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research Uses
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").
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 89 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. |
Country | Name | City | State |
---|---|---|---|
United States | iSpecimen | Huntsville | Alabama |
United States | iSpecimen | Lexington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
iSpecimen Inc |
United States,
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 |
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