Collection and Distribution of Biospecimens for Novel Research

NCT05080907 | Unknown

• 1 other identifier: ISPC-160630-REM/RUO/
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 7

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").

Conditions

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

Keywords

biospecimen; blood; urine

Outcome Measures

Primary Outcomes (1)

• Collection of Biospecimens for Novel Research Uses

  Repository of diseased and healthy tissue, blood derivatives and related biological specimens

  10 years

Secondary Outcomes (1)

• Number of subjects enrolled

  10 years

Interventions

Observational OTHER

Subjects for observational study Various conditions \& healthy subjects

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• iSpecimen Inc: lead

Study Sites (7)

Central Alabama

Birmingham, Alabama, 35005, United States

Location

Northern Alabama

Huntsville, Alabama, 35649, United States

Location

Southern Alabama Area

Mobile, Alabama, 36525, United States

Location

Central Alabama

Montgomery, Alabama, 36043, United States

Location

Western New York

Buffalo, New York, 14221, United States

Location

Greater Philadelphia Area

Philadelphia, Pennsylvania, 19102, United States

Location

Western Pennsylvania

Pittsburgh, Pennsylvania, 15201, United States

Location

Related Links

• iSpecimen was founded to address a critical challenge: how to connect life science researchers who need human biospecimens with the billions of specimens available in healthcare organizations worldwide.

MeSH Terms

Conditions

Neoplasms; Autoimmune Diseases; Communicable Diseases; Skin Diseases; Hematologic Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Immune System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 18, 2021
• Study Start: July 15, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)