RecruitingNCT06967532

Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients

Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients - A Prospective Non-interventional Single-arm Study


Sponsor

Medical University of Vienna

Enrollment

90 participants

Start Date

Sep 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

First discovered in 1997 the torque teno virus (TTV) can be found in the vast majority of the human population throughout their lifetime. The TTV levels correlate with infectious diseases and organ rejection and are therefore currently being investigated as a tool to optimize the management of patients after solid organ transplantation (SOT). While TTV levels are already tested to guide immunosuppressive therapy its significance for oncologic patients is unclear. In recent years immune checkpoint inhibitors (ICIs) are increasingly implemented in multimodal therapy approaches for patients with non-small-cell lung cancer (NSCLC). Since ICI and TTV levels depend on T-cell function, the TTV load may be a relevant biomarker for the treatment response as well as complication risk after ICI therapy. Current standard imaging using PERCIST and RECIST criteria is prone to misinterpretation of treatment response of ICI therapy due to pseudoprogression and nodal immune flaring. This study aims to prospectively analyze TTV levels in NSCLC patients before, during and after neoadjuvant chemo-immunotherapy and correlate inter- and intraindividual changes in TTV levels with response rates observed on PET/CT restaging and histopathological response rates as well as postoperative outcome.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a common virus called Torque Teno Virus (TTV) — which most people carry without knowing it — can help predict how well lung cancer patients respond to immunotherapy treatments and how they recover after surgery. **You may be eligible if...** - You have non-small cell lung cancer (NSCLC) at stage II, III, or IV - Your cancer team has decided surgery with the goal of a cure is possible after you receive immunotherapy first - You are in generally good physical condition (able to carry out normal daily activities) - You have had recent PET/CT and brain imaging scans **You may NOT be eligible if...** - Your cancer has not been confirmed by a biopsy or tissue test - You are not well enough to undergo surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood test

Blood sampling


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT06967532


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