ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: 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
This is a prospective observational study that will collect blood samples at 1-10 timepoints related to initiation of immunotherapy. The study may collect samples before the start of immunotherapy and/or at clinically significant timepoints during immunotherapy treatment.
Detailed description
The long-term goal of this research is to identify immunologic and other blood-borne markers of immunotherapy efficacy and toxicity. The objective of this proposal is to identify associations between immunologic parameters and other blood-borne markers with treatment response, irAE development, or relevant biomarkers of both outcomes.
Primary outcome measures
- Quantification of plasma concentrations [Time frame: through study completion (i.e. up to 12 months)]
- Profiling of immune cells [Time frame: through study completion (i.e. up to 12 months)]
Secondary outcome measures (1)
- Assessment of genomic variants [Time frame: through study completion (i.e. up to 12 months)]
Eligibility criteria
Inclusion criteria
- ≥ 18 years old at the time of informed consent.
- Have a diagnosis of cancer and initiating therapy with single agent or combination therapy that includes an immunotherapy (see Appendix 16.1 for list of immunotherapy classes).
- Ability to provide written informed consent and HIPAA authorization.
Exclusion criteria
1\. Not meeting any of the previously described inclusion criteria.
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
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
Identifiers
NCT: NCT06900296 · PHARM-IUSCCC-0913