Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies

August 16, 2023 updated by: Masonic Cancer Center, University of Minnesota

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients receiving care in the University of Minnesota Blood and Marrow Transplant Program

Description

Inclusion Criteria:

  • Patients planning to undergo HCT or other cellular therapy/immunotherapy
  • Allogeneic related donors
  • Aged 0-80
  • Willing and able to sign voluntary written consent

Exclusion Criteria:

  • Patients whose medical record indicates that they have opted out of research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Immune and Microbial Reconstitution
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Diagnostic test: Stool Sample
pea-sized amount
Diagnostic test: Urine Sample
10 ml
Immune Response Triggered by Severe, Systemic Viral Infection
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Diagnostic test: Bronchoalveolar Lavage (BAL) fluid
10 ml
Immune Response Triggered by Acute Graft-versus-Host Disease
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Diagnostic test: Stool Sample
pea-sized amount
Diagnostic test: Gastrointestinal biopsy x 2-4
rectosigmoid site preferred
Diagnostic test: Skin biopsy
2-4 mm punch
Immune Response Triggered by Chronic Graft-versus-Host Disease
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Diagnostic test: Skin biopsy
2-4 mm punch
Diagnostic test: Skin, mouth, and/or ocular swab
Involved skin, mouth, and/or ocular swab for microbiota studies
Immune Response Triggered by Relapse
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Immune Response Triggered by Cytokine Release Syndrome
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Allogeneic Related Donor Samples
Diagnostic test: Blood Sample
60 ml heparinized blood 10 ml serum
Diagnostic test: Stool Sample
pea-sized amount
Diagnostic test: Urine Sample
10 ml
Cellular Therapy Products
Diagnostic test: Apheresis Product
Up to 10 ml of apheresis product
Diagnostic test: Final cellular product
A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immune Function after HCT
Time Frame: 7 Years
Incidence of neutrophil recovery
7 Years
Immune Function after HCT
Time Frame: 7 Years
Incidence of lymphocyte and monocyte subset recovery
7 Years
Immune Function after HCT
Time Frame: 7 Years
Incidence of grade II-IV acute GVHD
7 Years
Immune Function after HCT
Time Frame: 7 Years
Incidence of CMV reactivation
7 Years
Immune Function after Cell Therapy/Immunotherapy
Time Frame: 7 Years
Incidence of neutrophil recovery
7 Years
Immune Function after Cell Therapy/Immunotherapy
Time Frame: 7 Years
Incidence of lymphocyte and monocyte subset recovery
7 Years
Immune Function after Cell Therapy/Immunotherapy
Time Frame: 7 Years
Incidence of cytokine release syndrome (CRS)
7 Years
Correlate Immune Parameters
Time Frame: 7 Years
Correlate the lymphocyte phenotypes, specifically natural killer cell subsets and lymphocyte response to viral antigen.
7 Years
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
7 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017NTLS045
  • MT2017-12 (Other Identifier: Masonic Cancer Center, University of Minnesota)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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