Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
NCT ID: NCT03557749
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
210 participants
OBSERVATIONAL
2018-09-21
2023-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Immune and Microbial Reconstitution
Blood Sample
60 ml heparinized blood 10 ml serum
Stool Sample
pea-sized amount
Urine Sample
10 ml
Immune Response Triggered by Severe, Systemic Viral Infection
Blood Sample
60 ml heparinized blood 10 ml serum
Bronchoalveolar Lavage (BAL) fluid
10 ml
Immune Response Triggered by Acute Graft-versus-Host Disease
Blood Sample
60 ml heparinized blood 10 ml serum
Stool Sample
pea-sized amount
Gastrointestinal biopsy x 2-4
rectosigmoid site preferred
Skin biopsy
2-4 mm punch
Immune Response Triggered by Chronic Graft-versus-Host Disease
Blood Sample
60 ml heparinized blood 10 ml serum
Skin biopsy
2-4 mm punch
Skin, mouth, and/or ocular swab
Involved skin, mouth, and/or ocular swab for microbiota studies
Immune Response Triggered by Relapse
Blood Sample
60 ml heparinized blood 10 ml serum
Immune Response Triggered by Cytokine Release Syndrome
Blood Sample
60 ml heparinized blood 10 ml serum
Allogeneic Related Donor Samples
Blood Sample
60 ml heparinized blood 10 ml serum
Stool Sample
pea-sized amount
Urine Sample
10 ml
Cellular Therapy Products
Apheresis Product
Up to 10 ml of apheresis product
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
Interventions
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Blood Sample
60 ml heparinized blood 10 ml serum
Stool Sample
pea-sized amount
Urine Sample
10 ml
Bronchoalveolar Lavage (BAL) fluid
10 ml
Gastrointestinal biopsy x 2-4
rectosigmoid site preferred
Skin biopsy
2-4 mm punch
Skin, mouth, and/or ocular swab
Involved skin, mouth, and/or ocular swab for microbiota studies
Apheresis Product
Up to 10 ml of apheresis product
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
Eligibility Criteria
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Inclusion Criteria
* Allogeneic related donors
* Aged 0-80
* Willing and able to sign voluntary written consent
Exclusion Criteria
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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MT2017-12
Identifier Type: OTHER
Identifier Source: secondary_id
2017NTLS045
Identifier Type: -
Identifier Source: org_study_id
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