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Trial Title:
Immune Profiling for Cancer Immunotherapy Response
NCT ID:
NCT06116032
Condition:
Cancer
Tumor, Solid
Hematologic Malignancy
Blood Cancer
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
Immunotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Methylation Cytometry
Description:
Assessment of the ability of Methylation Cytometry in pre-treatment peripheral blood and
in repeated measures over the duration of treatment to predict treatment response or
occurrence of adverse events.
Arm group label:
Bone Marrow Transplant
Arm group label:
CAR T
Arm group label:
Standard of Care Checkpoint
Summary:
In patients clinically treated with FDA-approved immunotherapy the investigators will
assess the predictive value of pre- and on-treatment 1) immune-methylation profiling
across cancer types, and 2) immune-methylation profiling and cytokine profiling within
cancer types.
Criteria for eligibility:
Study pop:
Cancer patients who will receive or who are receiving immunotherapy under FDA- approved
indication
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Cancer patients receiving or will receive immunotherapy under FDA- approved
indication (e.g. checkpoint inhibitor therapy with pembrolizumab, nivolumab, or
ipilimumab, or cellular immunotherapy).
- Participants are eligible regardless of the type of prior therapy (i.e. prior
immunotherapy treated participants can be included).
Exclusion Criteria:
- Pregnant women/fetuses/neonates
- Prisoners
- Decision-impaired individuals
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dartmouth-Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hannah G Stolrow, BA
Phone:
720-517-4950
Email:
hannah.stolrow@dartmouth.edu
Investigator:
Last name:
Brock C Christensen, PhD
Email:
Principal Investigator
Start date:
October 3, 2022
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116032
