NCT06967532Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 3 May 2025
- Start date
- 6 Sept 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Medical University of Vienna
- Diseases
- Lung cancer
- NCT number
- NCT06967532
What you commit to
- Study type: Observational
- Planned participants: 90
- From 6 Sept 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \-
Who the study is looking for
- \- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.