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The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers. (TIOB)

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ClinicalTrials.gov Identifier: NCT05371756
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : May 12, 2022
Sponsor:
Collaborator:
Translational Genomics Research Institute
Information provided by (Responsible Party):
Baylor Research Institute

Tracking Information
First Submitted Date April 27, 2022
First Posted Date May 12, 2022
Last Update Posted Date May 12, 2022
Actual Study Start Date September 11, 2020
Estimated Primary Completion Date September 11, 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2022)
  • Develop a biorepository [ Time Frame: 30 years ]
    Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and aligned clinical data for development of new diagnostic and therapeutic technology.
  • Release of specimens [ Time Frame: 30 years ]
    Implement release of specimens from biorepository for testing.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 11, 2022)
  • Laboratory Testing [ Time Frame: 30 years ]
    Immunohistochemistry
  • Laboratory Testing [ Time Frame: 30 years ]
    Genomic and Molecular analysis including circulating cell free DNA/RNA
  • Laboratory Testing [ Time Frame: 30 years ]
    Proteomic analysis
  • Laboratory Testing [ Time Frame: 30 years ]
    Single cell and Spatial transcriptomics
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.
Official Title The Texas Immuno-Oncology Biorepository: Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers That Predict Benefit/Resistance to Cancer Therapeutics.
Brief Summary The purpose of the Texas Immuno-Oncology Biorepository (TIOB) is to collect and store well-defined and well-annotated serial biospecimens of tissue, blood, urine and stool in a longitudinal manner from cancer patients who are receiving either standard of care surgical interventions and or FDA approved immunotherapeutics across the largest not-for-profit health system in Texas. Comprehensive clinical and radiological data from a diverse population of patients with different racial, social and ethnic backgrounds matched with serial biospecimens over a patients journey with cancer marks the TIOB as a unique research facility.
Detailed Description The goal of establishing the Texas Immuno-Oncology Biorepository (TIOB) is to create a research facility that purposely consents patients to collect, catalog, process, store, and analyze biospecimens with well-annotated clinical/radiological data from patients receiving surgical interventions or immunotherapeutics in our combined clinics throughout Texas. Potential types of studies that will be enabled by this resource will include but are not limited to (a) morphological studies including immunohistochemistry, (b) genomic and molecular analysis, including circulating, cell-free DNA, RNA, as well as extracellular vesicles and their cargo, (c) proteomic analysis involving protein isolation, (d) interrogation of circulating immune cells as well as the underlying tumor immune microenvironment, and (e) single-cell and spatial transcriptomics. Correlation of these studies with clinical, treatment outcome, and demographic information will be possible. Translation of multi-omics technologies will be a key feature of the TIOB and data integration strategies including genomics, epigenomics, transcriptomics, proteomics, radiomics, metabolomics and microbiomics will be possible and offer opportunities to improve our understanding of the complex biological interactions that define cancer.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 30 Years
Biospecimen Retention:   Samples With DNA
Description:
TIOB will collect tissue, bodily fluids, and blood samples.
Sampling Method Non-Probability Sample
Study Population Patients due to receive or who have received immunotherapeutic drugs.
Condition Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2022)		 100000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 11, 2052
Estimated Primary Completion Date September 11, 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Understand and willingness to sign written informed consent method.
  • Patients who are suspected by a physician of being at risk for developing cancer.
  • Patients with confirmed or clinically suspected malignancy by a physician. This includes but is not limited to candidates for immunotherapy, surgical candidates, patients receiving Standard of Care drugs, immunotherapy drugs, participating on a clinical trial with immunotherapy drugs, patients who have received immunotherapy drugs in the past, patients with any other approved or investigational disease management.

Exclusion Criteria:

  • Patients unwilling to donate blood
  • Patients unwilling to provide informed consent for the collection of fresh or archived tumor tissue.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Sido Oghenevovwero, MS 214-820-6168 ext 42-6168 corcsolidtumor@BSWHealth.org
Contact: Keisha Riser, MBA 214-820-8165 ext 42-8165 keisha.riser@bswhealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05371756
Other Study ID Numbers 019-350
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Baylor Research Institute
Original Responsible Party Same as current
Current Study Sponsor Baylor Research Institute
Original Study Sponsor Same as current
Collaborators Translational Genomics Research Institute
Investigators
Principal Investigator: Ronan Kelly, MD Baylor Scott & White Research Institute
PRS Account Baylor Research Institute
Verification Date April 2022