ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06900296

Acronym

INTERPRET

Enrollment

100

Registered

2025-03-28

Start date

2028-01-01

Completion date

2029-04-01

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

immunotherapy treatment

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. ≥ 18 years old at the time of informed consent. 2. 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). 3. Ability to provide written informed consent and HIPAA authorization.

Exclusion criteria

1\. Not meeting any of the previously described inclusion criteria.

Design outcomes

Primary

Measure	Time frame	Description
Quantification of plasma concentrations	through study completion (i.e. up to 12 months)	Including cytokines, chemokines, growth factors, and other relevant immunologic molecules from blood samples
Profiling of immune cells	through study completion (i.e. up to 12 months)	Plasma concentrations of immunologic molecules will be assayed using immunoassays or plasma proteomic approaches. Profiling of immune cells will be performed using flow cytometry, RNA sequencing, and other established approaches.

Secondary

Measure	Time frame	Description
Assessment of genomic variants	through study completion (i.e. up to 12 months)	Whole genome sequencing of germline DNA isolated from blood samples.

Countries

United States

Contacts

CONTACTRoss Robinson

rossrobi@iu.edu(317)274-2744

CONTACTTyler Shugg, PharmD, PhD

tshugg@iu.edu(317)278-3054

PRINCIPAL_INVESTIGATORTyler Shugg, PharmD, PhD

Indiana University

Outcome results