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Trial record 1 of 3 for:    iSpecimen
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Collection and Distribution of Biospecimens for Novel Research Uses

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ClinicalTrials.gov Identifier: NCT03848962
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
iSpecimen Inc

Study Description
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Brief 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").

Condition or disease
Cancer Healthy Gastrointestinal Complication Autoimmune Diseases Infectious Disease Women's Health: High-Risk Pregnancy Dermatologic Disease Blood Disease

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research Uses
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026
Groups and Cohorts
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Group/Cohort
Subjects for observational study
Various conditions & healthy subjects


Outcome Measures
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Primary Outcome Measures :
  1. Collection of Biospecimens for Novel Research Uses [ Time Frame: 10 years ]
    Repository of diseased and healthy tissue, blood derivatives and related biological specimens


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
iSpecimen will specify the population for screening and biospecimen collection, based on current research requests submitted to iSpecimen by researchers. All potential participants whose diagnoses, demographic profile, and/or clinically indicated care are consistent with the specified criteria for the collection will be considered eligible to participate.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848962


Contacts
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Contact: Emily L Hubbard 2567970003 ehubbard@ispecimen.com

Locations
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United States, Alabama
iSpecimen Recruiting
Huntsville, Alabama, United States, 35801
Contact: Emily L Hubbard    256-797-0003    ehubbard@ispecimen.com   
United States, Massachusetts
iSpecimen Active, not recruiting
Lexington, Massachusetts, United States, 02420
Sponsors and Collaborators
iSpecimen Inc
More Information
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Responsible Party: iSpecimen Inc
ClinicalTrials.gov Identifier: NCT03848962    
Other Study ID Numbers: ISPC-160630-REM/RUO
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Hematologic Diseases
Skin Diseases
 Autoimmune Diseases
Disease Attributes
Pathologic Processes
Immune System Diseases