CancerTIOBNCT05371756
The TIOB - Collection of Patients' Biospecimens for Analysis of Immunological and Molecular Biomarkers.
An observational study of Cancer, run by Baylor Research Institute at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 10,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Sep 2020to 11 Sep 2050
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected/confirmed cancers undergoing standard of care surgeries or with confirmed cancers receiving immunotherapeutic treatments.
Who may be able to join
- Participant is over 18 years of age at the time of signing the informed consent form.
- Participant is able and willing to sign an informed consent form.
- Participant is suspected by a provider of being at risk for developing cancer,
- OR
- Participant has confirmed or clinically suspected malignancy by a provider. This includes but is not limited to:
- Participants who may be candidates for or are scheduled to receive standard of care immunotherapy treatment for the first time for their current cancer diagnosis, regardless of any prior non-immunotherapy treatment.
- Participants who are enrolled in a clinical trial to receive an investigational, novel immunotherapy drug for the first time for their current cancer diagnosis.
- Participants who may be surgical candidates for their current cancer diagnosis, regardless of any prior treatment.
Who cannot join
- Participant is unable or unwilling to donate blood.
- Concurrent medical or psychiatric condition or disease that may compromise the ability to give documented informed consent, is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Baylor Scott & White Medical Center - College Station
College Station, Texas, 77845
Dedra L Preece, 254-724-5939, TIOBReferral@BSWHealth.org
- Recruiting
Baylor University Medical Center - Dallas
Dallas, Texas, 75246
Pukar Ratti, MSChE, MSHCM, 214-818-8472, TIOBReferral@BSWHealth.org
Ronan J Kelly, MD, MBA
- Recruiting
Baylor Scott & White All Saints Medical Center - Fort Worth
Fort Worth, Texas, 76104
Pukar Ratti, MSChE, MSHCM, 214-818-8472, TIOBReferral@BSWHealth.org
- Recruiting
Baylor Scott & White Medical Center - Plano
Plano, Texas, 75093
Pukar Ratti, MSChE, MSHCM, 214-818-8472, TIOBReferral@BSWHealth.org
- Recruiting
Baylor Scott & White Medical Center - Round Rock
Round Rock, Texas, 78665
Dedra L Preece, 254-724-5939, TIOBReferral@BSWHealth.org
- Recruiting
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
Dedra L Preece, 254-724-5939, TIOBReferral@BSWHealth.org
- Recruiting
Baylor Scott & White Medical Center - Hillcrest
Waco, Texas, 76712
Dedra L Preece, 254-724-5939, TIOBReferral@BSWHealth.org
- Recruiting
Baylor Scott & White Medical Center - Waxahachie
Waxahachie, Texas, 75165
Pukar Ratti, MSChE, MSHCM, 214-818-8472, TIOBReferral@BSWHealth.org
About this study
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.
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.
Read the 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.
- Conditions
- Cancer
- Keywords
- Biorepository, Immuno-Oncology, Molecular Biomarkers, Benefit & Resistance
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Early stage, operable cancers | |
| Immunotherapy | Metastatic, non-operable cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a biorepository
Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated patho-clinical data for development of new diagnostic and therapeutic technology.
Measured: 15 years
Secondary outcomes (1)
Release of Specimens
Promote and implement release of specimens from biorepository for further research utilization including but 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.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start11 Sep 2020
- Primary completion11 Sep 2035 (estimated)
- Study completion11 Sep 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Responsible party
- Sponsor
- Investigators
- Ronan J Kelly, MD, MBA, Principal investigator, Baylor Scott & White Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371756
- Sponsor's protocol ID
- 019-350
- Acronym
- TIOB
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team is still evaluating this further.
Publications
Yehuda Brody et al. Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA. ISLB 2025.
Yehonatan Elon et al. Longitudinal plasma proteomic analysis: A monitoring strategy for NSCLC patients treated with immunotherapy.. J Clin Oncol 43, 8579-8579(2025). DOI:10.1200/JCO.2025.43.16_suppl.8579
Kelly RJ, Whitsett TG, Snipes GJ, Dobin SM, Finholt J, Settele N, Priest EL, Youens K, Wallace LB, Schwartz G, Wong L, Henderson SM, Gowan AC, Fonkem E, Juarez MI, Murray CE, Wu J, Van Keuren-Jensen K, Pirrotte P, Highlander S, Contente T, Baker A, Victorino J, Berens ME. The Texas Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling. Proc (Bayl Univ Med Cent). 2022 Aug 26;36(1):1-7. doi: 10.1080/08998280.2022.2114129. eCollection 2023.
PubMed 36578607
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05371756
- Acronym / sponsor ID
- TIOB / 019-350
- Conditions
- Cancer
- Keywords
- Biorepository, Immuno-Oncology, Molecular Biomarkers, Benefit & Resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 11 Sep 2035 (estimated)
- Study completion
- 11 Sep 2050 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | –Early stage, operable cancers |
| Immunotherapy | – | –Metastatic, non-operable cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected/confirmed cancers undergoing standard of care surgeries or with confirmed cancers receiving immunotherapeutic treatments.
Key inclusion criteria (8 listed)
- Participant is over 18 years of age at the time of signing the informed consent form.
- Participant is able and willing to sign an informed consent form.
- Participant is suspected by a provider of being at risk for developing cancer,
- OR
- Participant has confirmed or clinically suspected malignancy by a provider. This includes but is not limited to:
Key exclusion criteria (2 listed)
- Participant is unable or unwilling to donate blood.
- Concurrent medical or psychiatric condition or disease that may compromise the ability to give documented informed consent, is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a biorepository
Time frame: 15 years
Develop a biorepository that ensures molecular integrity and clinical relevance of quality human biospecimens and associated patho-clinical data for development of new diagnostic and therapeutic technology.
1 secondary outcome
Release of Specimens
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publicationYehuda Brody et al. Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA. ISLB 2025.
- Results publicationYehonatan Elon et al. Longitudinal plasma proteomic analysis: A monitoring strategy for NSCLC patients treated with immunotherapy.. J Clin Oncol 43, 8579-8579(2025). DOI:10.1200/JCO.2025.43.16_suppl.8579
- Results publication: PubMed 36578607Kelly RJ, Whitsett TG, Snipes GJ, Dobin SM, Finholt J, Settele N, Priest EL, Youens K, Wallace LB, Schwartz G, Wong L, Henderson SM, Gowan AC, Fonkem E, Juarez MI, Murray CE, Wu J, Van Keuren-Jensen K, Pirrotte P, Highlander S, Contente T, Baker A, Victorino J, Berens ME. The Texas Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling. Proc (Bayl Univ Med Cent). 2022 Aug 26;36(1):1-7. doi: 10.1080/08998280.2022.2114129. eCollection 2023.
- Individual participant dataSharing planned: Undecided. The study team is still evaluating this further.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronan J Kelly, MD, MBA principal investigator
Baylor Scott & White Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Baylor Research Institute at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pukar Ratti, MSChE, MSHCM (214-818-8472, TIOBReferral@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a biorepository (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371756, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.