B2RAD Translational Medicine Study

• 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
• Interventions: Other: Specimen Collection

• Registration Number: NCT05292430
• Lead Sponsor: Sohail Rao

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-22
• Status Verified: 2022-03
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-23
• Last Update Posted: 2022-03-23
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biobank	Specimen Collection	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

DHR Health Institute for Research and Development; 🇺🇸 Edinburg, Texas, United States

DHR Health; 🇺🇸 Edinburg, Texas, United States