NCT07366008

The NorCUP Trial: Improving Prognosis and Personalized Treatment in Cancer of Unknown Primary (CUP)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to improve diagnosis and treatment strategies for patients with Cancer of Unknown Primary (CUP) by using advanced molecular profiling to identify the likely tumor origin and guide therapy. The main questions it aims to answer are: Can comprehensive molecular profiling help determine the origin of CUP tumors? Does identifying the tumor origin improve treatment choices and survival outcomes compared to historical data? Participants will: * Undergo a new biopsy to collect tumor tissue for advanced analyses. * Provide blood samples for circulating tumor DNA (cfDNA/ctDNA) analyses. * Provide a fecal sample for microbiome analysis. * Have their tumor tissue analyzed using: Methylation profiling and comprehensive gene panel testing. * Have the results reviewed in a specialized CUP molecular MDT meeting to determine the likely tumor origin and guide treatment. * Have their tumor tissue samples biobanked for further exploratory whole genome sequencing (WGS) and RNA sequencing.

Conditions

• Cancer of Unknown Primary Site

Interventions

Type	Name	Description
GENETIC	Comprehensive molecular profiling	A fresh frozen biopsy and blood plasma for cfDNA analyses is taken upon inclusion for comprehensive molecular profiling. Results are discussed at a study specific CUP molecular MDT meeting.

Timeline

• Start date: 2026-01-01
• Primary completion: 2033-01-01
• Completion: 2033-01-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

6 sites across 1 country: Norway