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NCT Number: NCT06900296

ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location contact

Ross Robinson

CONTACT

[email protected]

317-274-2744

Tyler Shugg, PharmD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Not meeting any of the previously described inclusion criteria.

Treatment and study plan

Primary outcomes

  1. Quantification of plasma concentrations

    Time frame: through study completion (i.e. up to 12 months)

    Including cytokines, chemokines, growth factors, and other relevant immunologic molecules from blood samples

  2. Profiling of immune cells

    Time frame: 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 outcomes

  1. Assessment of genomic variants

    Time frame: through study completion (i.e. up to 12 months)

    Whole genome sequencing of germline DNA isolated from blood samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Ross Robinson

CONTACT

[email protected]

(317)274-2744

Tyler Shugg, PharmD, PhD

CONTACT

[email protected]

(317)278-3054

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana Institute of Personalized Medicine

Registry information

Acronym: INTERPRET

Important dates

Study start
2028
Primary completion
2029
Study completion
2029
First posted
Mar 28, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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