CancerNCT03884400
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
An observational study of Cancer and Pregnancy Related, run by iSpecimen Inc at 1 site in United States.
Trial summary
This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer, Pregnancy Related, Gastro-Intestinal Disorder
- What is being tested?
- Specimens obtained from surgical, phlebotomy or other non-invasive procedure
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Diverse group of biorepositories with focus on cancer, neurodegenerative, pediatric, women's health and other cohorts.
Who may be able to join
- Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed.
- Specimens from biobanks that have collected materials and de-identified data under a waiver of consent
- Specimens from a biobank that meet the criteria for non human subject research under the common rule.
Who cannot join
- Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.
Read the detailed description
iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.
Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.
This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.
- Conditions
- Cancer, Pregnancy Related, Gastro-Intestinal Disorder, Cardio-Respiratory Distress, Women's Health: Endometriosis, Autoimmune Diseases
- Being tested
- Specimens obtained from surgical, phlebotomy or other non-invasive procedure
- Keywords
- Observational
- Medical subject headings
- Neoplasms, Digestive System Diseases, Autoimmune Diseases, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimens obtained from surgical, phlebotomy or other non-invasive procedureProcedure or surgery
Biospecimen Collection
| Study group | Role | What they receive |
|---|---|---|
| Subjects who have provided consent for specimen collection | Re-consent will not be required. This protocol allows distribution of the specimens following the terms agreed to by the subject in the original consent. Receives: Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
The number of specimens and subjects distributed per disease will be measured and reported.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Why it stopped: We have changed our research focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSpecimen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884400
- Sponsor's protocol ID
- ISPC-180828-DISTRIBUTION
- Status last verified
- Nov 2022
- First submitted
- 18 Mar 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
- ClinicalTrials.gov ID
- NCT03884400
- Acronym / sponsor ID
- ISPC-180828-DISTRIBUTION
- Conditions
- Cancer, Pregnancy Related, Gastro-Intestinal Disorder, Cardio-Respiratory Distress, Women's Health: Endometriosis, Autoimmune Diseases
- Keywords
- Observational
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We have changed our research focus
- Enrolment
- 0 participants (actual)
- Lead sponsor
- iSpecimen IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.
Detailed description
iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.
Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.
This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who have provided consent for specimen collection | – | Procedure: Specimens obtained from surgical, phlebotomy or other non-invasive procedureRe-consent will not be required. This protocol allows distribution of the specimens following the terms agreed to by the subject in the original consent. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diverse group of biorepositories with focus on cancer, neurodegenerative, pediatric, women's health and other cohorts.
Key inclusion criteria (3 listed)
- Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed.
- Specimens from biobanks that have collected materials and de-identified data under a waiver of consent
- Specimens from a biobank that meet the criteria for non human subject research under the common rule.
Key exclusion criteria (1 listed)
- Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimens obtained from surgical, phlebotomy or other non-invasive procedureBiospecimen Collection | Procedure or surgery | Subjects who have provided consent for specimen collection |
Primary outcome
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
Time frame: 15 years
The number of specimens and subjects distributed per disease will be measured and reported.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Website for specimen distributionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pregnancy Related, run by iSpecimen Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Biospecimens From Biorepositories/Biobanks for Research Use (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.