Collection and Distribution of Biospecimens for Novel Research Uses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03848962|
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : July 28, 2020
|Condition or disease|
|Cancer Healthy Gastrointestinal Complication Autoimmune Diseases Infectious Disease Women's Health: High-Risk Pregnancy Dermatologic Disease Blood Disease|
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 :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||iSpecimen Network Protocol: Collection and Distribution of Remnant and Research Use Only Biospecimens for Novel Research Uses|
|Actual Study Start Date :||June 30, 2016|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2026|
Subjects for observational study
Various conditions & healthy subjects
- Collection of Biospecimens for Novel Research Uses [ Time Frame: 10 years ]Repository of diseased and healthy tissue, blood derivatives and related biological specimens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848962
|Contact: Emily L Hubbardfirstname.lastname@example.org|
|Contact: Jill Mullanemail@example.com|
|United States, Massachusetts|
|iSpecimen||Active, not recruiting|
|Lexington, Massachusetts, United States, 02420|
|United States, North Carolina|
|Vidant Multispecialty Clinic-Kinston||Recruiting|
|Kinston, North Carolina, United States, 28501|
|Contact: Susan S Wiley 252-559-2200 ext 1328 Susan.Wiley@VidantHealth.com|
|Principal Investigator:||Christopher Ianelli, MD, PhD||iSpecimen Inc|