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Trial record 2 of 3 for:    iSpecimen

Collection and Distribution of Biospecimens for Novel Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05080907
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2021
Last Update Posted : November 9, 2022
Sponsor:
Information provided by (Responsible Party):
iSpecimen Inc

Tracking Information
First Submitted Date September 23, 2021
First Posted Date October 18, 2021
Last Update Posted Date November 9, 2022
Actual Study Start Date July 15, 2016
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2021)
Collection of Biospecimens for Novel Research Uses [ Time Frame: 10 years ]
Repository of diseased and healthy tissue, blood derivatives and related biological specimens
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 4, 2021)
Number of subjects enrolled [ Time Frame: 10 years ]
Each subject will have contributed at least one biospecimen
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection and Distribution of Biospecimens for Novel Research
Official Title iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cancer
  • Healthy
  • Gastrointestinal Complication
  • Autoimmune Diseases
  • Infectious Disease
  • Women's Health: High-Risk Pregnancy
  • Dermatologic Disease
  • Blood Disease
Intervention Other: Observational
Subjects for observational study Various conditions & healthy subjects
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 4, 2021)
100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05080907
Other Study ID Numbers ISPC-160630-REM/RUO/
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party iSpecimen Inc
Original Responsible Party Same as current
Current Study Sponsor iSpecimen Inc
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account iSpecimen Inc
Verification Date November 2022