Inflammatory Bowel DiseasesNCT03415919
Collection of Gastrointestinal Malignant and Non-malignant Human Samples
An observational study of Inflammatory Bowel Diseases and Colo-rectal Cancer, run by University of Texas at Austin at 1 site in United States.
Trial summary
To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colo-rectal Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: No special populations are targeted for accrual to this study. However, racial background may play a role in disease etiology, and a variety of races is optimal for this study to address that question. Thus, the patient's race information will be included with the sample.
Who may be able to join
- Biopsy-proven colorectal cancer scheduled to have surgical resection of primary site, at participating and approved facilities. Since it is standard clinical care to resect certain suspicious gastrointestinal masses without a pre-existing biopsy, patients who are undergoing resections for highly suspicious masses believed to be cancer, may be consented.
- Diagnosed with Inflammatory Bowel Disease (IBD) or Crohn's Disease (CD), scheduled to have biopsy and/or fecal collection.
- scheduled to have a colonoscopy as part of routine screening.
- 18 years old.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- The study will not exclude potential subjects from participation on the basis of ethnic origin or gender. Subjects recruited will include men, women, and all ethnic origins, provided they meet all inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
About this study
To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases.
Read the detailed description
The purpose of the proposed research is to collect tissue, blood and fecal samples from patients undergoing standard of care for their gastrointestinal disease, including Inflammatory Bowel Disease (IBD), and Colorectal Cancer (CRC). Tissue and blood samples will be obtained during procedures that are part of normal treatment, including blood and fecal collection, surgical resection, and biopsy collection. Samples will be obtained from consenting patients at Seton Dell Medical Center at the University of Texas (SDMCUT), or other relevant facilities (see section 6.i below), and only tissue not required for histopathological analysis will be collected. Initially, the focus will be on IBD, and CRC, where there are extensive previous studies to draw from.
The collected samples of the proposed study will be used to establish biomimetic human organ-on-a-chip platforms by leveraging microfluidic tissue culture technology. Another focus of the research will be study the human intestinal microbiome that is highly associated with the pathogenesis of human gastrointestinal diseases. The investigators have developed the microchip technology to mimic the structure and physiological function of human intestine by integrating tools developed in a microfluidic device, tissue engineering, and clinical microbiology, using intestinal cell lines. To recreate more reliable intestinal disease models and to further investigate the host-gut microbiome interactions in these experimental platforms, the investigators are transitioning to use human clinical samples. The investigators will use tissue biopsies to culture human intestinal cells including epithelium, endothelium, connective tissues on-chip. Blood samples will also obtained to isolate peripheral blood mononuclear cells (PBMC) that represent mixed population of white blood cells (WBC). Isolated WBCs will be co-cultured with intestinal cells. Any potential application of microbiome-related therapies such as fecal microbiota transplantation (FMT) will also be further investigated.
- Conditions
- Inflammatory Bowel Diseases, Colo-rectal Cancer
- Being tested
- no intervention will be given to patients.
- Medical subject headings
- Inflammatory Bowel Diseases, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention will be given to patients.Other
samples are collected at the time of a scheduled procedure that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Patients suffering from IBD scheduled to have a biopsy by colonoscopy. Receives: Other: no intervention will be given to patients. | |
| CRC patients | Patients suffering from CRC scheduled to have a biopsy by colonoscopy, or surgical resection of colon. Receives: Other: no intervention will be given to patients. | |
| Control patients | Patients who are scheduled to have a colonoscopy for routine screening to serve as a control population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirmation of diagnosis by pathologist
Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.
Measured: directly following procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start13 Jul 2018
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jung Kim, University of Texas at Austin
- Investigators
- Hyun Jung Kim, PhD, Principal investigator, Assistant ProfessorRichard D Fleming, MD, FACS, Principal investigator, Associate Director for Surgical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415919
- Sponsor's protocol ID
- IRB 2017-06-0114
- Status last verified
- Jun 2021
- First submitted
- 16 Jan 2018
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no protected health information will be shared with other researchers. Experimental data, and samples obtained during this study may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Gastrointestinal Malignant and Non-malignant Human Samples
- ClinicalTrials.gov ID
- NCT03415919
- Acronym / sponsor ID
- IRB 2017-06-0114
- Conditions
- Inflammatory Bowel Diseases, Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 30 Jan 2018 (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.
To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases.
Detailed description
The purpose of the proposed research is to collect tissue, blood and fecal samples from patients undergoing standard of care for their gastrointestinal disease, including Inflammatory Bowel Disease (IBD), and Colorectal Cancer (CRC). Tissue and blood samples will be obtained during procedures that are part of normal treatment, including blood and fecal collection, surgical resection, and biopsy collection. Samples will be obtained from consenting patients at Seton Dell Medical Center at the University of Texas (SDMCUT), or other relevant facilities (see section 6.i below), and only tissue not required for histopathological analysis will be collected. Initially, the focus will be on IBD, and CRC, where there are extensive previous studies to draw from.
The collected samples of the proposed study will be used to establish biomimetic human organ-on-a-chip platforms by leveraging microfluidic tissue culture technology. Another focus of the research will be study the human intestinal microbiome that is highly associated with the pathogenesis of human gastrointestinal diseases. The investigators have developed the microchip technology to mimic the structure and physiological function of human intestine by integrating tools developed in a microfluidic device, tissue engineering, and clinical microbiology, using intestinal cell lines. To recreate more reliable intestinal disease models and to further investigate the host-gut microbiome interactions in these experimental platforms, the investigators are transitioning to use human clinical samples. The investigators will use tissue biopsies to culture human intestinal cells including epithelium, endothelium, connective tissues on-chip. Blood samples will also obtained to isolate peripheral blood mononuclear cells (PBMC) that represent mixed population of white blood cells (WBC). Isolated WBCs will be co-cultured with intestinal cells. Any potential application of microbiome-related therapies such as fecal microbiota transplantation (FMT) will also be further investigated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Other: no intervention will be given to patients.Patients suffering from IBD scheduled to have a biopsy by colonoscopy. |
| CRC patients | – | Other: no intervention will be given to patients.Patients suffering from CRC scheduled to have a biopsy by colonoscopy, or surgical resection of colon. |
| Control patients | – | –Patients who are scheduled to have a colonoscopy for routine screening to serve as a control population. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No special populations are targeted for accrual to this study. However, racial background may play a role in disease etiology, and a variety of races is optimal for this study to address that question. Thus, the patient's race information will be included with the sample.
Key inclusion criteria (5 listed)
- Biopsy-proven colorectal cancer scheduled to have surgical resection of primary site, at participating and approved facilities. Since it is standard clinical care to resect certain suspicious gastrointestinal masses without a pre-existing biopsy, patients who are undergoing resections for highly suspicious masses believed to be cancer, may be consented.
- Diagnosed with Inflammatory Bowel Disease (IBD) or Crohn's Disease (CD), scheduled to have biopsy and/or fecal collection.
- scheduled to have a colonoscopy as part of routine screening.
- Ability to understand and willingness to sign a written informed consent document.
Key exclusion criteria (1 listed)
- The study will not exclude potential subjects from participation on the basis of ethnic origin or gender. Subjects recruited will include men, women, and all ethnic origins, provided they meet all inclusion criteria listed above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention will be given to patients.samples are collected at the time of a scheduled procedure that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives. | Other | CRC patients, IBD patients |
Primary outcome
confirmation of diagnosis by pathologist
Time frame: directly following procedure
Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: Undecided. no protected health information will be shared with other researchers. Experimental data, and samples obtained during this study may be shared with other researchers.
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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. This study is not recruiting at the moment.
Hyun Jung Kim, PhD principal investigator
Assistant Professor
Richard D Fleming, MD, FACS principal investigator
Associate Director for Surgical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Colo-rectal Cancer, run by University of Texas at Austin at 1 site 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
confirmation of diagnosis by pathologist (time frame: directly following procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2021.