Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05080907 |
| Other study ID # |
ISPC-160630-REM/RUO/ |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2016 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
November 2022 |
| Source |
iSpecimen Inc |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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").
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.
