Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow DrawB2RADNCT05292430
B2RAD Translational Medicine Study
An observational study of Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow Draw, run by Sohail Rao at 2 sites in United States.
Trial summary
Recent advances in understanding the molecular and cellular pathology of many diseases have resulted in direct benefit to today's patients. The translational research studies that have led to these advances relied on an integrated model of clinical and non-clinical laboratory investigations based on the analysis of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow Draw
- What is being tested?
- Specimen Collection
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2020to Dec 2022
- How long will I take part?
- 1 Day
- 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: Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included.
Who may be able to join
- Any subject choosing to give consent for participation will be included.
- Any subject in which the primary diagnosis of cancer was made at the DHR Health System.
Who cannot join
- Any subject deemed unable to provide legally effective consent.
- Any pediatric subject where the subject does not freely give his or her assent or where his or her parent/guardian does not give consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Sohail Rao, MD, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 9563623223, m.betancourt@dhr-rgv.com
- Recruiting
DHR Health
Edinburg, Texas, 78539
Sohail Rao, MD, 956-362-2387, s.rao@dhr-rgv.com
Monica Betancourt-Garcia, MD, 956-362-3223, m.betancourt@dhr-rgv.com
About this study
Recent advances in understanding the molecular and cellular pathology of many diseases have resulted in direct benefit to today's patients. The translational research studies that have led to these advances relied on an integrated model of clinical and non-clinical laboratory investigations based on the analysis of human biospecimens that lead directly to drug discovery, drug validation, novel detection assays, and prognostic marker discovery. Translational research provides a unique mechanism to address questions specific to particular tumor or other disease types, biological modifiers and/or mechanisms of action that are essential for the advancement of healthcare. Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included
- Being tested
- Specimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen CollectionOther
collection of diseased and non-diseased tissue, blood, and other body fluids
| Study group | Role | What they receive |
|---|---|---|
| Biobank | Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included. Receives: Other: Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of diseased and non-diseased tissue, blood, and other body fluids
Collection of diseased and non-diseased tissue, blood, and other body fluids to establish a biobank to evaluate all potential clinically relevant alterations in the diseased cells, cellular components and disease biomarkers. The methods used to identify these alterations include: 1) Creation of novel disease and normal cell lines; 2) Molecular analysis; 3) Protein analysis; and 4) other cellular analyses. These methods may be employed immediately after obtaining the biologic material or at a future date after samples have been stored in a bank.
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start22 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow DrawStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohail Rao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sohail Rao, DHR Health Institute for Research and Development
- Investigators
- Sohail Rao, MD, Principal investigator, DHR Heath Institute for Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292430
- Sponsor's protocol ID
- 1551551
- Acronym
- B2RAD
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 23 Mar 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B2RAD Translational Medicine Study
- ClinicalTrials.gov ID
- NCT05292430
- Acronym / sponsor ID
- B2RAD / 1551551
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sohail RaoUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Mar 2022 (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.
Recent advances in understanding the molecular and cellular pathology of many diseases have resulted in direct benefit to today's patients. The translational research studies that have led to these advances relied on an integrated model of clinical and non-clinical laboratory investigations based on the analysis of human biospecimens that lead directly to drug discovery, drug validation, novel detection assays, and prognostic marker discovery. Translational research provides a unique mechanism to address questions specific to particular tumor or other disease types, biological modifiers and/or mechanisms of action that are essential for the advancement of healthcare. Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biobank | – | Other: Specimen CollectionSpecimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specimens are to be collected from subjects who are having or have had a surgical or medical procedure (such as fluid or tissue removed, a biopsy or a blood or bone marrow draw). Any subject in which the primary diagnosis of disease was made within the DHR Health System and Any subject choosing to give consent for participation will be included.
Key inclusion criteria (2 listed)
- Any subject choosing to give consent for participation will be included.
- Any subject in which the primary diagnosis of cancer was made at the DHR Health System.
Key exclusion criteria (2 listed)
- Any subject deemed unable to provide legally effective consent.
- Any pediatric subject where the subject does not freely give his or her assent or where his or her parent/guardian does not give consent.
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 |
|---|---|---|
| Specimen Collectioncollection of diseased and non-diseased tissue, blood, and other body fluids | Other | Biobank |
Primary outcome
Collection of diseased and non-diseased tissue, blood, and other body fluids
Time frame: once
Collection of diseased and non-diseased tissue, blood, and other body fluids to establish a biobank to evaluate all potential clinically relevant alterations in the diseased cells, cellular components and disease biomarkers. The methods used to identify these alterations include: 1) Creation of novel disease and normal cell lines; 2) Molecular analysis; 3) Protein analysis; and 4) other cellular analyses. These methods may be employed immediately after obtaining the biologic material or at a future date after samples have been stored in a bank.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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.
Sohail Rao, MD principal investigator
DHR Heath Institute for Research and Development
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow Draw, run by Sohail Rao at 2 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohail Rao, MD (956-362-2387, s.rao@dhr-rgv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of diseased and non-diseased tissue, blood, and other body fluids (time frame: once). 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 23 Mar 2022.