Inflammatory Bowel DiseasesNCT05769829
ImmuneSense™ IBD Study
An observational study of Inflammatory Bowel Diseases, run by Adaptive Biotechnologies at 6 sites in United States.
Trial summary
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase. Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 484 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Oct 2022to 14 Aug 2023
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms Participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment Participants recently diagnosed with IBD but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached. Cohort 3: Potential Cross-Reactive Diseases Participants with confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease. Cohort 4: Healthy Controls Participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness.
Who may be able to join
None listed.
Who cannot join
- Age <7 years or >89 years
- Known IBD (Ulcerative colitis, Crohn's disease, indeterminate colitis) and Celiac
- Known active malignancy
- Active Hepatitis B, C or HIV infection(s)
- Use of systemic high dose corticosteroids (above 20mg/day prednisone by mouth) within 30 days prior to the blood draw
- Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
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- Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
- Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
- Cohort 2: Diagnosed IBD, Pre-treatment Inclusion criteria
- Diagnosis of Crohn's disease or Ulcerative colitis made with endoscopy (within 6 months), clinical, imaging, and histological findings.
- Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
- Must be able to communicate with the investigator, understand and comply with the requirements of the study
- Age <7 years or >89 years
- Known active malignancy
- Known Celiac disease
- Active Hepatitis B, C or HIV infection(s)
- Active gastrointestinal infection within 30 days prior to enrollment
- Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
- Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
- Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
- On any treatment for IBD- systemic corticosteroids within 30 days, immunomodulator, 5-ASA, biologic therapy
- Plan to initiate therapy as part of a clinical trial of a non-FDA-approved IBD therapy
- Cohort 3: Potential Cross-Reactive Disease States Inclusion criteria
- Confirmed, documented diagnoses for one of the following diseases:
- Irritable Bowel Syndrome, Functional Diarrhea (Endoscopy negative for inflammation)
- Celiac disease (Serology positive (ttg IgA+) AND Upper endoscopy confirming Celiac disease diagnosis)
- Diverticulitis, and other forms of microscopic colitis
- Infectious etiologies: E. coli, Klebsiella pneumoniae, Salmonella spp., Shigella spp., Yersinia spp (Positive stool culture or PCR)
- For infections, active infections are required or within 30 days of infection.
- Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
- Must be able to communicate with the investigator, understand and comply with the requirements of the study
- Age <7 years or >89
- Individuals with a prior or current clinical diagnosis of IBD
- Active Hepatitis B, C or HIV infection(s)
- Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
- Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
- Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
- Cohort 4: Healthy Controls Inclusion criteria
- Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
- Must be able to communicate with the investigator, understand and comply with the requirements of the study Exclusion criteria
- Age <7 years or >89
- GI symptoms in last 90 days (Abdominal pain, diarrhea, blood in stool, weight loss, vomiting)
- Individuals with a prior or current clinical diagnosis of IBD, Celiac disease, active infection
- Family history of Crohn's disease, indeterminate colitis or ulcerative colitis
- Active Hepatitis B, C or HIV infection(s)
- Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
- Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
- Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Gastroenterology Consultants of South Texas, PA
Brownsville, Texas, 78526
Hope Clinic & Research Center LLC
Hialeah, Florida, 33010
Gold Coast Health Research Center, LLC
Miami, Florida, 33155
Sanitas Research
Miami, Florida, 33155
University Gastroenterology
Providence, Rhode Island, 02904
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
About this study
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.
Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only.
Read more
CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls.
AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, Ulcerative colitis, Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
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 |
|---|---|---|
| Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms | Up to 450 participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy. In addition to the 450 participants enrolled, 50 more participants that meet inclusion/exclusion for cohort 1 will be enrolled to complete only the initial visit and endoscopy visit. Participants will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. | |
| Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment | Up to 400 participants recently diagnosed with inflammatory bowel disease but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy. | |
| Cohort 3: Potential Cross-Reactive Diseases | Patients will be eligible for this cohort if they fail to be diagnosed with inflammatory bowel disease but have a confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease. | |
| Cohort 4: Healthy Controls | Up to 228 participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of T-Detect IBD
To evaluate the sensitivity and specificity of T-Detect IBD, by interrogating the peripheral T cell repertoire for TCRs enhanced in IBD, to aid in diagnosis of IBD.
To evaluate the sensitivity and specificity of T-Detect IBD relative to endoscopy with biopsies.
To evaluate the sensitivity and specificity of T-Detect IBD as a prognostic marker for medication response.
Measured: Initial Study visit/Baseline
Secondary outcomes (1)
Future/Additional research
Samples not allocated to primary objective may be used for additional research and/or development, and clinical and analytical development/validation efforts may utilize samples collected from this study.
Measured: Initial Study visit/Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start31 Oct 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Why it stopped: Enrollment challenges for cohort 2
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.
- 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
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptive Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769829
- Sponsor's protocol ID
- PRO-01038
- Status last verified
- Oct 2023
- First submitted
- 11 Jan 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmuneSense™ IBD Study
- ClinicalTrials.gov ID
- NCT05769829
- Acronym / sponsor ID
- PRO-01038
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD, Ulcerative colitis, Crohn's disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment challenges for cohort 2
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Adaptive BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 15 Mar 2023 (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.
This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.
Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only.
CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls.
AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms | – | –Up to 450 participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy. In addition to the 450 participants enrolled, 50 more participants that meet inclusion/exclusion for cohort 1 will be enrolled to complete only the initial visit and endoscopy visit. Participants will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. |
| Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment | – | –Up to 400 participants recently diagnosed with inflammatory bowel disease but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached. Additional blood draws at various timepoints during the study; at follow up visits, at time of flare, medication change, surgery, or repeat endoscopy. |
| Cohort 3: Potential Cross-Reactive Diseases | – | –Patients will be eligible for this cohort if they fail to be diagnosed with inflammatory bowel disease but have a confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease. |
| Cohort 4: Healthy Controls | – | –Up to 228 participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: Pre-diagnosis/+Gastrointestinal Symptoms Participants with gastrointestinal symptoms, undergoing endoscopy with biopsy will have blood drawn, metadata collected, and tissue from endoscopy collected for analysis. Cohort 2: Diagnosed Inflammatory Bowel Disease, Pre-treatment Participants recently diagnosed with IBD but not yet started on a medication regimen to address their symptoms will have blood drawn with metadata attached. Cohort 3: Potential Cross-Reactive Diseases Participants with confirmed diagnosis of potential cross reactive disease states including Irritable Bowel Syndrome, Functional Diarrhea, Celiac Disease. Cohort 4: Healthy Controls Participants free from GI symptoms for the last 90 days and no previous medical history or clinical diagnosis of GI illness.
Key inclusion criteria (0 listed)
Key exclusion criteria (48 listed)
- Age <7 years or >89 years
- Known IBD (Ulcerative colitis, Crohn's disease, indeterminate colitis) and Celiac
- Known active malignancy
- Active Hepatitis B, C or HIV infection(s)
- Use of systemic high dose corticosteroids (above 20mg/day prednisone by mouth) within 30 days prior to the blood draw
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
Sensitivity and specificity of T-Detect IBD
Time frame: Initial Study visit/Baseline
To evaluate the sensitivity and specificity of T-Detect IBD, by interrogating the peripheral T cell repertoire for TCRs enhanced in IBD, to aid in diagnosis of IBD. To evaluate the sensitivity and specificity of T-Detect IBD relative to endoscopy with biopsies. To evaluate the sensitivity and specificity of T-Detect IBD as a prognostic marker for medication response.
1 secondary outcome
Future/Additional research
Time frame: Initial Study visit/Baseline
Results and safety
The study was stopped early (reason given: Enrollment challenges for cohort 2). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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, run by Adaptive Biotechnologies at 6 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 0 inclusion and 48 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: stopped early, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was stopped early (reason given: Enrollment challenges for cohort 2). 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?
Sensitivity and specificity of T-Detect IBD (time frame: Initial Study visit/Baseline). 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 5 Oct 2023.