Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06967532
Acronym
TTV in NSCLC
Enrollment
90
Registered
2025-05-13
Start date
2024-09-06
Completion date
2026-09-30
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC (Non-small Cell Lung Cancer)

Brief 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.

Interventions

DIAGNOSTIC_TESTBlood test

Blood sampling

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Histologically or cytologically verified NSCLC stage II-IV (OMD) according to UICC TNM8 edition considered operable in curative intent after neoadjuvant systemic therapy containing immune checkpoint inhibition by local multidisciplinary tumor board (MDT) decision. ECOG \< or = 1 Staging with PET/CT and cMRI/CCT Written informed consent

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Histopathological response to neoadjuvant chemo-immunotherapy2 years

Countries

Austria

Contacts

Primary ContactClemens Aigner, MD, MBA, FETCS
clemens.aigner@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026