ImmuNe ParameTERs to Predict Immunotherapy REsponse and T... | NCT06900296

Studies
ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)

NCT06900296

Sponsor

Indiana University

Status

Not yet recruiting

Last Update Posted

Oct 16, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

Apr 2029Estimated

Completion Date

Apr 2029Estimated

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2025

Last Update Posted Date

Oct 16, 2025Actual

Name	Class
Indiana Institute of Personalized Medicine	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantification of plasma concentrations	Including cytokines, chemokines, growth factors, and other relevant immunologic molecules from blood samples	through study completion (i.e. up to 12 months)
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.	through study completion (i.e. up to 12 months)

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults diagnosed with cancer and initiating immunotherapy treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ross Robinson	Contact	(317)274-2744		rossrobi@iu.edu
Tyler Shugg, PharmD, PhD	Contact	(317)278-3054		tshugg@iu.edu

Overall Officials

Name	Affiliation	Role
Tyler Shugg, PharmD, PhD	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Melvin and Bren Simon Comprehensive Cancer Center		Indianapolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided