Collection and Distribution of Biospecimens for Novel Research

November 8, 2022 updated by: iSpecimen Inc

iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research

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").

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35005
        • Central Alabama
      • Huntsville, Alabama, United States, 35649
        • Northern Alabama
      • Mobile, Alabama, United States, 36525
        • Southern Alabama Area
      • Montgomery, Alabama, United States, 36043
        • Central Alabama
    • New York
      • Buffalo, New York, United States, 14221
        • Western New York
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Greater Philadelphia Area
      • Pittsburgh, Pennsylvania, United States, 15201
        • Western Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Collection of Biospecimens for Novel Research Uses
Time Frame: 10 years
Repository of diseased and healthy tissue, blood derivatives and related biological specimens
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of subjects enrolled
Time Frame: 10 years
Each subject will have contributed at least one biospecimen
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
iSpecimen Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ISPC-160630-REM/RUO/

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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