Clinical Trials Directory

Trials / Terminated

TerminatedNCT03557749

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

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

Status
Terminated
Phase
—
Study type
Observational
Enrollment
210 (actual)
Sponsor
Masonic Cancer Center, University of Minnesota · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood Sample60 ml heparinized blood 10 ml serum
DIAGNOSTIC_TESTStool Samplepea-sized amount
DIAGNOSTIC_TESTUrine Sample10 ml
DIAGNOSTIC_TESTBronchoalveolar Lavage (BAL) fluid10 ml
DIAGNOSTIC_TESTGastrointestinal biopsy x 2-4rectosigmoid site preferred
DIAGNOSTIC_TESTSkin biopsy2-4 mm punch
DIAGNOSTIC_TESTSkin, mouth, and/or ocular swabInvolved skin, mouth, and/or ocular swab for microbiota studies
DIAGNOSTIC_TESTApheresis ProductUp to 10 ml of apheresis product
DIAGNOSTIC_TESTFinal cellular productA second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product

Timeline

Start date
2018-09-21
Primary completion
2023-06-30
Completion
2023-08-15
First posted
2018-06-15
Last updated
2023-08-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03557749. Inclusion in this directory is not an endorsement.