Immune and Microbial ReconstitutionNCT03557749
Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
An observational study of Immune and Microbial Reconstitution and Systemic Viral Infection, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune and Microbial Reconstitution, Systemic Viral Infection, Acute-graft-versus-host Disease
- What is being tested?
- Blood Sample, Stool Sample and Urine Sample
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 15 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program
Who may be able to join
- Patients planning to undergo HCT or other cellular therapy/immunotherapy
- Allogeneic related donors
- Aged 0-80
- Willing and able to sign voluntary written consent
Who cannot join
- Patients whose medical record indicates that they have opted out of research
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).
- Conditions
- Immune and Microbial Reconstitution, Systemic Viral Infection, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Recurrent Malignancy, Cytokine Release Syndrome
- Being tested
- Blood Sample, Stool Sample, Urine Sample, Bronchoalveolar Lavage (BAL) fluid, Gastrointestinal biopsy x 2-4
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Neoplasms, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleDiagnostic test
60 ml heparinized blood 10 ml serum
Stool SampleDiagnostic test
pea-sized amount
Urine SampleDiagnostic test
10 ml
Bronchoalveolar Lavage (BAL) fluidDiagnostic test
10 ml
Gastrointestinal biopsy x 2-4Diagnostic test
rectosigmoid site preferred
Skin biopsyDiagnostic test
2-4 mm punch
Skin, mouth, and/or ocular swabDiagnostic test
Involved skin, mouth, and/or ocular swab for microbiota studies
Apheresis ProductDiagnostic test
Up to 10 ml of apheresis product
Final cellular productDiagnostic test
A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product
| Study group | Role | What they receive |
|---|---|---|
| Immune and Microbial Reconstitution | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample | |
| Immune Response Triggered by Severe, Systemic Viral Infection | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid | |
| Immune Response Triggered by Acute Graft-versus-Host Disease | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Gastrointestinal biopsy x 2-4; Diagnostic Test: Skin biopsy | |
| Immune Response Triggered by Chronic Graft-versus-Host Disease | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Skin biopsy; Diagnostic Test: Skin, mouth, and/or ocular swab | |
| Immune Response Triggered by Relapse | Not described Receives: Diagnostic Test: Blood Sample | |
| Immune Response Triggered by Cytokine Release Syndrome | Not described Receives: Diagnostic Test: Blood Sample | |
| Allogeneic Related Donor Samples | Not described Receives: Diagnostic Test: Blood Sample; Diagnostic Test: Stool Sample; Diagnostic Test: Urine Sample | |
| Cellular Therapy Products | Not described Receives: Diagnostic Test: Apheresis Product; Diagnostic Test: Final cellular product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Function after HCT
Incidence of neutrophil recovery
Measured: 7 Years
Immune Function after HCT
Incidence of lymphocyte and monocyte subset recovery
Measured: 7 Years
Immune Function after HCT
Incidence of grade II-IV acute GVHD
Measured: 7 Years
Immune Function after HCT
Incidence of CMV reactivation
Measured: 7 Years
Immune Function after Cell Therapy/Immunotherapy
Incidence of neutrophil recovery
Measured: 7 Years
Immune Function after Cell Therapy/Immunotherapy
Incidence of lymphocyte and monocyte subset recovery
Measured: 7 Years
Immune Function after Cell Therapy/Immunotherapy
Incidence of cytokine release syndrome (CRS)
Measured: 7 Years
Correlate Immune Parameters
Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
Measured: 7 Years
Correlate microbiota changes and their interactions with the host with outcomes of HCT
Correlate microbiota changes and their interactions with the host with outcomes of HCT
Measured: 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start21 Sep 2018
- Primary completion30 Jun 2023
- Study completion15 Aug 2023
Why it stopped: Accrual goal met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune and Microbial ReconstitutionStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557749
- Sponsor's protocol ID
- 2017NTLS045
- Other IDs
- MT2017-12
- Status last verified
- Aug 2023
- First submitted
- 15 May 2018
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Immune and Microbial Reconstitution in Hematopoietic Cell Transplantation (HCT) and Novel Immunotherapies
- ClinicalTrials.gov ID
- NCT03557749
- Acronym / sponsor ID
- 2017NTLS045
- Conditions
- Immune and Microbial Reconstitution, Systemic Viral Infection, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease, Recurrent Malignancy, Cytokine Release Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual goal met
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 15 Jun 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.
This protocol serves as a mechanism to collect, store, and distribute bodily fluid and tissue samples obtained from Hematopoietic Cell Transplant (HCT) or novel immunotherapy patients and their donors at the Masonic Cancer Center in order to conduct correlative studies of the immune system, microbiota, and their interactions. Fluid (including but not limited to, blood, urine, saliva, cerebrospinal fluid, bronchoalveolar lavage fluid) sample log-in, processing, relabeling, and storage is performed by the Masonic Cancer Center (MCC) Translational Therapy Lab (TTL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Immune and Microbial Reconstitution | – | Diagnostic Test: Blood Sample, Diagnostic Test: Stool Sample, Diagnostic Test: Urine Sample |
| Immune Response Triggered by Severe, Systemic Viral Infection | – | Diagnostic Test: Blood Sample, Diagnostic Test: Bronchoalveolar Lavage (BAL) fluid |
| Immune Response Triggered by Acute Graft-versus-Host Disease | – | Diagnostic Test: Blood Sample, Diagnostic Test: Stool Sample, Diagnostic Test: Gastrointestinal biopsy x 2-4, Diagnostic Test: Skin biopsy |
| Immune Response Triggered by Chronic Graft-versus-Host Disease | – | Diagnostic Test: Blood Sample, Diagnostic Test: Skin biopsy, Diagnostic Test: Skin, mouth, and/or ocular swab |
| Immune Response Triggered by Relapse | – | Diagnostic Test: Blood Sample |
| Immune Response Triggered by Cytokine Release Syndrome | – | Diagnostic Test: Blood Sample |
| Allogeneic Related Donor Samples | – | Diagnostic Test: Blood Sample, Diagnostic Test: Stool Sample, Diagnostic Test: Urine Sample |
| Cellular Therapy Products | – | Diagnostic Test: Apheresis Product, Diagnostic Test: Final cellular product |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program
Key inclusion criteria (4 listed)
- Patients planning to undergo HCT or other cellular therapy/immunotherapy
- Allogeneic related donors
- Aged 0-80
- Willing and able to sign voluntary written consent
Key exclusion criteria (1 listed)
- Patients whose medical record indicates that they have opted out of research
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 |
|---|---|---|
| Blood Sample60 ml heparinized blood 10 ml serum | Diagnostic test | Allogeneic Related Donor Samples, Immune Response Triggered by Acute Graft-versus-Host Disease, Immune Response Triggered by Chronic Graft-versus-Host Disease, Immune Response Triggered by Cytokine Release Syndrome, Immune Response Triggered by Relapse, Immune Response Triggered by Severe, Systemic Viral Infection, Immune and Microbial Reconstitution |
| Stool Samplepea-sized amount | Diagnostic test | Allogeneic Related Donor Samples, Immune Response Triggered by Acute Graft-versus-Host Disease, Immune and Microbial Reconstitution |
| Urine Sample10 ml | Diagnostic test | Allogeneic Related Donor Samples, Immune and Microbial Reconstitution |
| Bronchoalveolar Lavage (BAL) fluid10 ml | Diagnostic test | Immune Response Triggered by Severe, Systemic Viral Infection |
| Gastrointestinal biopsy x 2-4rectosigmoid site preferred | Diagnostic test | Immune Response Triggered by Acute Graft-versus-Host Disease |
| Skin biopsy2-4 mm punch | Diagnostic test | Immune Response Triggered by Acute Graft-versus-Host Disease, Immune Response Triggered by Chronic Graft-versus-Host Disease |
| Skin, mouth, and/or ocular swabInvolved skin, mouth, and/or ocular swab for microbiota studies | Diagnostic test | Immune Response Triggered by Chronic Graft-versus-Host Disease |
| Apheresis ProductUp to 10 ml of apheresis product | Diagnostic test | Cellular Therapy Products |
| Final cellular productA second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product | Diagnostic test | Cellular Therapy Products |
Primary outcome
Immune Function after HCT
Time frame: 7 Years
Incidence of neutrophil recovery
Immune Function after HCT
Time frame: 7 Years
Incidence of lymphocyte and monocyte subset recovery
Immune Function after HCT
Time frame: 7 Years
Incidence of grade II-IV acute GVHD
Immune Function after HCT
Time frame: 7 Years
Incidence of CMV reactivation
Immune Function after Cell Therapy/Immunotherapy
Time frame: 7 Years
Incidence of neutrophil recovery
Immune Function after Cell Therapy/Immunotherapy
Time frame: 7 Years
Incidence of lymphocyte and monocyte subset recovery
Immune Function after Cell Therapy/Immunotherapy
Time frame: 7 Years
Incidence of cytokine release syndrome (CRS)
Correlate Immune Parameters
Time frame: 7 Years
Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
Correlate microbiota changes and their interactions with the host with outcomes of HCT
Time frame: 7 Years
Correlate microbiota changes and their interactions with the host with outcomes of HCT
Results and safety
The study was stopped early (reason given: Accrual goal met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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.
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 Immune and Microbial Reconstitution and Systemic Viral Infection, run by Masonic Cancer Center, University of Minnesota 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 4 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: stopped early, as of the sponsor's last update on 21 Aug 2023. 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?
The study was stopped early (reason given: Accrual goal met). 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?
Immune Function after HCT (time frame: 7 Years). The study lists 9 primary outcomes in all. 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 21 Aug 2023.