Collection and Distribution of Biospecimens for Novel Research

Sponsor

iSpecimen Inc (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05080907

Collaborator

(none)

100,000

Enrollment

Locations

101.6

Anticipated Duration (Months)

10000

Patients Per Site

98.4

Patients Per Site Per Month

Study Details

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").

Condition or Disease	Intervention/Treatment	Phase
Cancer Healthy Gastrointestinal Complication Autoimmune Diseases Infectious Disease Women's Health: High-Risk Pregnancy Dermatologic Disease Blood Disease	Other: Observational

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 Design

Study Type:

Observational

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2016

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Collection of Biospecimens for Novel Research Uses [10 years]
Repository of diseased and healthy tissue, blood derivatives and related biological specimens

Secondary Outcome Measures

Number of subjects enrolled [10 years]
Each subject will have contributed at least one biospecimen

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Alabama	Birmingham	Alabama	United States	35005
2	Northern Alabama	Huntsville	Alabama	United States	35649
3	Southern Alabama Area	Mobile	Alabama	United States	36525
4	Central Alabama	Montgomery	Alabama	United States	36043
5	Northern Arizona	Flagstaff	Arizona	United States	86001
6	Central Arizona	Phoenix	Arizona	United States	85001
7	South Central Arizona	Tucson	Arizona	United States	85641
8	Western New York	Buffalo	New York	United States	14221
9	Greater Philadelphia Area	Philadelphia	Pennsylvania	United States	19102
10	Western Pennsylvania	Pittsburgh	Pennsylvania	United States	15201