B2RAD Translational Medicine Study

NCT05292430 | Unknown

• 1 other identifier: 1551551
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Specimen Collection OTHER

collection of diseased and non-diseased tissue, blood, and other body fluids

Biobank

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohail Rao: lead

Study Sites (2)

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

RECRUITING

DHR Health

Edinburg, Texas, 78539, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fluid or tissue removed, a biopsy or a blood or bone marrow draw. The specimen requirements are approximately 80 mgs to 1 gm or more of fresh, frozen, or formalin fixed paraffin embedded ("FFPE") viable diseased tissue and up to 700 gms of viable normal tissue (when available). In addition, blood and/or bone marrow specimens may be obtained at diagnosis, during therapy, during remission, or at the time of relapse. Blood collection may range from 2-15tubes or approximately 20 to 150 mLs. Depending on the protocol it may be necessary to collect other biospecimens such as urine, stool, saliva, bronchial lavage, nasal fluids, or fine needle aspirates.

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Sohail Rao, MD

  DHR Heath Institute for Research and Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohail Rao, MD

CONTACT

956-362-2387; s.rao@dhr-rgv.com

Monica Betancourt-Garcia, MD

CONTACT

956-362-3223; m.betancourt@dhr-rgv.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President and CEO

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: January 22, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)