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

  • End date
    Jan 24, 2030
  • participants needed
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 24 March 2022


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).

Condition 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
Treatment Blood sample, Skin Biopsy, Urine Sample, stool sample, Bronchoalveolar Lavage (BAL) fluid, Gastrointestinal biopsy x 2-4, Skin, mouth, and/or ocular swab, Apheresis Product, Final cellular product
Clinical Study IdentifierNCT03557749
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on24 March 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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