NCT06900296

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
36mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Apr 2029

First Submitted

Initial submission to the registry

March 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

March 21, 2025

Last Update Submit

October 14, 2025

Conditions

Cancer

Keywords

immunotherapy treatment

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Assessment of genomic variants

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults diagnosed with cancer and initiating immunotherapy treatment

You may qualify if:

  • ≥ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study is observational in nature and will involve no medical interventions outside of collecting 1-10 blood samples at 1-10 separate study visits

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Tyler Shugg, PharmD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross Robinson

CONTACT

(317)274-2744rossrobi@iu.edu

Tyler Shugg, PharmD, PhD

CONTACT

(317)278-3054tshugg@iu.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 28, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

October 16, 2025

Record last verified: 2025-10

Locations

US(1)