B2RAD Translational Medicine Study

Sponsor
Sohail Rao (Other)
Overall Status
Recruiting
CT.gov ID
NCT05292430
Collaborator
(none)
1,000
2
34.3
500
14.6

Study Details

Study Description

Brief 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 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
B2RAD Translational Medicine Study
Actual Study Start Date :
Jan 22, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Specimen Collection
collection of diseased and non-diseased tissue, blood, and other body fluids

Outcome Measures

Primary Outcome Measures

  1. Collection of diseased and non-diseased tissue, blood, and other body fluids [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Any subject choosing to give consent for participation will be included.

  2. Any subject in which the primary diagnosis of cancer was made at the DHR Health System.

Exclusion Criteria:
  1. Any subject deemed unable to provide legally effective consent.

  2. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 DHR Health Institute for Research and Development Edinburg Texas United States 78539
2 DHR Health Edinburg Texas United States 78539

Sponsors and Collaborators

  • Sohail Rao

Investigators

  • Principal Investigator: Sohail Rao, MD, DHR Heath Institute for Research and Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sohail Rao, President and CEO, DHR Health Institute for Research and Development
ClinicalTrials.gov Identifier:
NCT05292430
Other Study ID Numbers:
  • 1551551
First Posted:
Mar 23, 2022
Last Update Posted:
Mar 23, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 23, 2022