NCT03557749

Brief 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 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

4.8 years

First QC Date

May 15, 2018

Last Update Submit

August 16, 2023

Conditions

Immune and Microbial ReconstitutionSystemic Viral InfectionAcute-graft-versus-host DiseaseChronic Graft-versus-host-diseaseRecurrent MalignancyCytokine Release SyndromeAllogenic Related DonorsCell Therapy/Immunotherapy Patients

Outcome Measures

Primary Outcomes (9)

  • Immune Function after HCT

    Incidence of neutrophil recovery

    7 Years

  • Immune Function after HCT

    Incidence of lymphocyte and monocyte subset recovery

    7 Years

  • Immune Function after HCT

    Incidence of grade II-IV acute GVHD

    7 Years

  • Immune Function after HCT

    Incidence of CMV reactivation

    7 Years

  • Immune Function after Cell Therapy/Immunotherapy

    Incidence of neutrophil recovery

    7 Years

  • Immune Function after Cell Therapy/Immunotherapy

    Incidence of lymphocyte and monocyte subset recovery

    7 Years

  • Immune Function after Cell Therapy/Immunotherapy

    Incidence of cytokine release syndrome (CRS)

    7 Years

  • Correlate Immune Parameters

    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

    Correlate microbiota changes and their interactions with the host with outcomes of HCT

    7 Years

Study Arms (8)

Immune and Microbial Reconstitution

Diagnostic Test: Blood SampleDiagnostic Test: Stool SampleDiagnostic Test: Urine Sample

Immune Response Triggered by Severe, Systemic Viral Infection

Diagnostic Test: Blood SampleDiagnostic Test: Bronchoalveolar Lavage (BAL) fluid

Immune Response Triggered by Acute Graft-versus-Host Disease

Diagnostic Test: Blood SampleDiagnostic Test: Stool SampleDiagnostic Test: Gastrointestinal biopsy x 2-4Diagnostic Test: Skin biopsy

Immune Response Triggered by Chronic Graft-versus-Host Disease

Diagnostic Test: Blood SampleDiagnostic Test: Skin biopsyDiagnostic 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 SampleDiagnostic Test: Stool SampleDiagnostic Test: Urine Sample

Cellular Therapy Products

Diagnostic Test: Apheresis ProductDiagnostic Test: Final cellular product

Interventions

Blood SampleDIAGNOSTIC_TEST

60 ml heparinized blood 10 ml serum

Allogeneic Related Donor SamplesImmune Response Triggered by Acute Graft-versus-Host DiseaseImmune Response Triggered by Chronic Graft-versus-Host DiseaseImmune Response Triggered by Cytokine Release SyndromeImmune Response Triggered by RelapseImmune Response Triggered by Severe, Systemic Viral InfectionImmune and Microbial Reconstitution
Stool SampleDIAGNOSTIC_TEST

pea-sized amount

Allogeneic Related Donor SamplesImmune Response Triggered by Acute Graft-versus-Host DiseaseImmune and Microbial Reconstitution
Urine SampleDIAGNOSTIC_TEST

10 ml

Allogeneic Related Donor SamplesImmune and Microbial Reconstitution
Bronchoalveolar Lavage (BAL) fluidDIAGNOSTIC_TEST

10 ml

Immune Response Triggered by Severe, Systemic Viral Infection
Gastrointestinal biopsy x 2-4DIAGNOSTIC_TEST

rectosigmoid site preferred

Immune Response Triggered by Acute Graft-versus-Host Disease
Skin biopsyDIAGNOSTIC_TEST

2-4 mm punch

Immune Response Triggered by Acute Graft-versus-Host DiseaseImmune Response Triggered by Chronic Graft-versus-Host Disease
Skin, mouth, and/or ocular swabDIAGNOSTIC_TEST

Involved skin, mouth, and/or ocular swab for microbiota studies

Immune Response Triggered by Chronic Graft-versus-Host Disease
Apheresis ProductDIAGNOSTIC_TEST

Up to 10 ml of apheresis product

Cellular Therapy Products
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

Cellular Therapy Products

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeNeoplasmsCytokine Release Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 15, 2018

Study Start

September 21, 2018

Primary Completion

June 30, 2023

Study Completion

August 15, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

US(1)