NCT06967532 Efficacy of Torque Teno Virus as a Biomarker for Predicting Treatment Response of Immune Checkpoint Inhibitor Therapy and Postoperative Outcome in NSCLC Patients
| NCT ID | NCT06967532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | NSCLC (Non-small Cell Lung Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-09-06 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2024-09-06 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06967532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06967532 currently recruiting?
Yes, NCT06967532 is actively recruiting participants. Contact the research team at clemens.aigner@meduniwien.ac.at for enrollment information.
Where is the NCT06967532 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06967532 clinical trial?
NCT06967532 is sponsored by Medical University of Vienna. The trial plans to enroll 90 participants.
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