Recruiting NCT06116032
Immune Profiling for Cancer Immunotherapy Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylation Cytometry.
- Who it may be relevant to
- Registry conditions: Cancer, Tumor, Solid, Hematologic Malignancy, Blood Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Methylation 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.
Primary outcome measures
- Response to therapy [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dartmouth-Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT06116032 · Study02001227