Blood Cancer, Cancer, Hematologic Malignancy, Tumor, Solid
Conditions
Keywords
Immunotherapy
Brief 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.
Interventions
DIAGNOSTIC_TESTMethylation Cytometry
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.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to therapy | 5 years | The investigators will employ iRECIST, and outcome criteria will be clinically evaluated and include the primary endpoints of progression (non-responders) or response, with patients followed up every month for 6 months (or until death, loss to follow-up, or withdrawal of consent), judged according to the objective response rate (ORR) assessed using iRECIST. |
Countries
United States
Contacts
Primary ContactBrock C Christensen, PhD
Backup ContactHannah G Stolrow, BA
Outcome results
None listed