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.
ECOG PS 0-2.
Life expectancy minimum 3 months.
Radiologically verified metastatic disease (CT thorax/abdomen/pelvis) with no radiological signs of primary tumor.
Histologically verified metastatic disease of unknown primary. Morphological and immunohistochemical findings suggesting a possible, but not definitive, origo is eligible.
Patients with any clinically significant medical or psychiatric condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements.
Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
Single group
Comprehensive molecular profiling
GeneticA 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.
Percentage of patients where the site of origin is identified
Site of origin identified is defined as the cases where the CUP molecular MDT concludes with a likely primary site of origin
Percentage of patients where treatment choice differs from empirical CUP regimen
Organ specific treatment chosen over empirical CUP treatment, based on the conclusion from the CUP MDT
Progression free survival
The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.
Overall survival
Length of time from CUP diagnosis until death from any cause
Identification of tumor site using molecular profiling methods
The percentage of patients in whom the likely site of origin is identified by each molecular profiling method.
Incidence of molecular alterations and use of targeted treatment in CUP patients
The frequency of molecular alterations and actionable targets in patients with CUP, and the percentage of patients receiving targeted therapy based on molecular profiling results. The impact of targeted treatment on survival will also be evaluated.
Fecal Microbiome Diversity and Composition in CUP Patient
Characterization of the fecal microbiome in patients with cancer of unknown primary (CUP)
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This trial is not recruiting at the moment. You can still explore other options:
