Collection and Distribution of 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").
Conditions:
🦠 Cancer 🦠 Healthy 🦠 Gastrointestinal Complication 🦠 Autoimmune Diseases 🦠 Infectious Disease 🦠 Women's Health: High-Risk Pregnancy 🦠 Dermatologic Disease 🦠 Blood Disease
🗓️ Study Start (Actual) 30 June 2016
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 10000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Huntsville, Alabama, United States
📍 Lexington, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 1 Month to 89 Years (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 February 2019
  • First Submitted that Met QC Criteria 19 February 2019
  • First Posted 21 February 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2022
  • Last Update Posted 9 November 2022
  • Last Verified November 2022