Collection and distribution of biospecimens for research purposes

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

This study is trying to see how collecting samples from healthy people and those with medical conditions can help researchers find new ways to diagnose and treat diseases.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 1 Month to 89 Years
• Sex: All
• Sponsor: iSpecimen Inc (industry)
• Locations: 2 sites (Huntsville, Alabama and 1 other locations)
• Trial ID: NCT03848962 on ClinicalTrials.gov

What this trial studies

This project aims to establish a network of hospitals, laboratories, and academic institutions to provide researchers with annotated biospecimens for various medical research applications. Participants, including both healthy individuals and those with medical conditions, will be approached during clinical care or through outreach programs to provide biospecimens. The study focuses on understanding the impact of specimen collection methods on research outcomes and facilitating biomarker discovery, diagnostic test development, and therapeutic advancements. Minimal risk screening activities will be conducted to determine eligibility for participation.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 7 years and older, both healthy and those with specific medical conditions relevant to ongoing research.

Not a fit: Patients who are younger than 7 years old or those who do not meet the specific eligibility criteria for biospecimen collection may not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could enhance the availability of biospecimens for critical medical research, leading to improved diagnostics and treatments.

How similar studies have performed: Other studies utilizing similar biospecimen collection approaches have shown promise in advancing medical research, indicating that this method is both tested and effective.

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.

Where this trial is running

Huntsville, Alabama and 1 other locations

• iSpecimen — Huntsville, Alabama, United States (RECRUITING)
• iSpecimen — Lexington, Massachusetts, United States (ACTIVE_NOT_RECRUITING)

Study contacts

• Study coordinator: Emily L Hubbard

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