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

NCT03557749 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2023-08-21

No results posted yet for this study

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).

Conditions

  • Immune and Microbial Reconstitution
  • Systemic Viral Infection
  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host-disease
  • Recurrent Malignancy
  • Cytokine Release Syndrome
  • Allogenic Related Donors
  • Cell Therapy/Immunotherapy Patients

Interventions

DIAGNOSTIC_TEST

Blood Sample

60 ml heparinized blood 10 ml serum

DIAGNOSTIC_TEST

Stool Sample

pea-sized amount

DIAGNOSTIC_TEST

Urine Sample

10 ml

DIAGNOSTIC_TEST

Bronchoalveolar Lavage (BAL) fluid

10 ml

DIAGNOSTIC_TEST

Gastrointestinal biopsy x 2-4

rectosigmoid site preferred

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

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

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2023-06-30
Completion
2023-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557749 on ClinicalTrials.gov