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Not yet recruitingNCT06900296INTERPRETUpdated Jul 15, 2026

ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)

An observational study in Cancer, sponsored by Indiana University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Indiana University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cancer

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Keywords

  • immunotherapy treatment
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

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Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults diagnosed with cancer and initiating immunotherapy treatment

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

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Quantification of plasma concentrations

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

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

  2. Profiling of immune cells

    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.

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

Secondary outcomes

  1. Assessment of genomic variants

    Whole genome sequencing of germline DNA isolated from blood samples.

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

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Study locations

1 site
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
    Indianapolis, Indiana 46202, United States
    • Ross Robinson · Contact · rossrobi@iu.edu · 317-274-2744
    • Tyler Shugg, PharmD, PhD · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06900296
Lead sponsor
Indiana University
Collaborators
Indiana Institute of Personalized Medicine
Responsible party
Tyler Andrew Shugg (Assistant Professor, Indiana University) — Principal investigator
First posted
Mar 28, 2025
Start date
Jan 2028 (estimated)
Primary completion
Apr 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Jul 15, 2026

Study contacts

Ross Robinson
Contact
rossrobi@iu.edu
(317)274-2744
Tyler Shugg, PharmD, PhD
Contact
tshugg@iu.edu
(317)278-3054
Tyler Shugg, PharmD, PhD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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