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History of Changes for Study: NCT03848962
Collection and Distribution of Biospecimens for Novel Research Uses
Latest version (submitted November 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 19, 2019 None (earliest Version on record)
2 July 27, 2020 Study Status
3 August 24, 2021 Study Status
4 August 30, 2021 Contacts/Locations and Study Status
5 August 4, 2022 Contacts/Locations and Study Status
6 November 8, 2022 Contacts/Locations and Study Status
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Study NCT03848962
Submitted Date:  February 19, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: ISPC-160630-REM/RUO
Brief Title: Collection and Distribution of Biospecimens for Novel Research Uses
Official Title: iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research Uses
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Recruiting
Study Start: June 30, 2016
Primary Completion: December 31, 2025 [Anticipated]
Study Completion: December 31, 2026 [Anticipated]
First Submitted: February 11, 2019
First Submitted that
Met QC Criteria:
February 19, 2019
First Posted: February 21, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
February 19, 2019
Last Update Posted: February 21, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: iSpecimen Inc
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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").
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.

Open or close this module Conditions
Conditions: Cancer
Healthy
Gastrointestinal Complication
Autoimmune Diseases
Infectious Disease
Women's Health: High-Risk Pregnancy
Dermatologic Disease
Blood Disease
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 10000 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Subjects for observational study
Various conditions & healthy subjects
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 1 Month
Maximum Age: 89 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Central Contact Person: Emily L Hubbard
Telephone: 2567970003
Email: ehubbard@ispecimen.com
Central Contact Backup: Jill Mullan
Telephone: 7813016688
Email: jmullan@ispecimen.com
Study Officials: Christopher Ianelli, MD, PhD
Principal Investigator
iSpecimen Inc
Locations: United States, Massachusetts
iSpecimen
[Active, not recruiting]
Lexington, Massachusetts, United States, 02420
United States, North Carolina
Vidant Multispecialty Clinic-Kinston
[Recruiting]
Kinston, North Carolina, United States, 28501
Contact:Contact: Susan S Wiley 252-559-2200 Ext. 1328 Susan.Wiley@VidantHealth.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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