B2RAD Translational Medicine Study (B2RAD)

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 Overview

• Status: Recruiting
• Conditions: 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
• Intervention / Treatment: Other: Specimen Collection

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Monica Betancourt-Garcia, MD; Phone Number: 956-362-3223; Email: m.betancourt@dhr-rgv.com

Study Locations

• United States
  • Texas
    • Edinburg, Texas, United States, 78539
      • Recruiting
      • DHR Health Institute for Research and Development
    • Edinburg, Texas, United States, 78539
      • Recruiting
      • DHR Health
      • Contact: Monica Betancourt-Garcia, MD; Phone Number: 956-362-3223; Email: m.betancourt@dhr-rgv.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	once

Collaborators and Investigators

• Sponsor: Sohail Rao

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (ACTUAL): March 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1551551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No