An interventional study of Comprehensive molecular profiling in Cancer of Unknown Primary Site, sponsored by Haukeland University Hospital. Not yet recruiting at 6 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Diagnostic
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:
Methylation profiling and comprehensive gene panel testing.
101 studies on the registry are indexed under Neoplasms, Unknown Primary; 19 are open to participants now.
This study's planned enrollment of 350 is above the median of 52 across 63 interventional studies indexed under Neoplasms, Unknown Primary.
Browse Neoplasms, Unknown Primary studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tumor methylation analyses, cfDNA methylation analyses, Whole Genome Sequencing, RNA sequencing, Broad targeted NGS panel analyses
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.
Also known as: whole genome sequencing, RNA sequencing, Tumor methylation analyses, cfDNA methylation analyses, Broad targeted NGS panel
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
Time frame: From enrollment to the conclusion at the CUP molecular MDT at 8 weeks
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
Time frame: From conclusion at the CUP molecular MDT to the start of subsequent treatment within a timeframe of 36 months from study inclusion
Progression free survival
The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.
Time frame: From the date of first administration of a treatment line to the date of progression or death, or censored if alive at time of analysis, with a timeframe of 36 months from study inclusion.
Overall survival
Length of time from CUP diagnosis until death from any cause
Time frame: From date of CUP diagnosis until death from any cause or censored if alive at date of analysis, within a timeframe of 36 months from study inclusion.
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.
Time frame: From study enrollment to the conclusion at the CUP molecular MDT at 8 weeks
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.
Time frame: From molecular profiling to initiation of targeted therapy and follow-up for survival outcomes, within a timeframe of 36 months from study inclusion.
Impact of CUP molecular MDT assessement on previous clinical work-up
This outcome evaluates the utility of CUP molecular MDT meetings by measuring the percentage of patients for whom additional clinical work-up or pathology analyses are recommended and the concordance between local and study pathologist conclusions.
Time frame: From enrollment until CUP mol MDT at 8 weeks
Fecal Microbiome Diversity and Composition in CUP Patient
Characterization of the fecal microbiome in patients with cancer of unknown primary (CUP)
Time frame: From baseline stool sample collection through completion of analyses within a timeframe of 36 months from study inclusion
Start is estimated for Jan 2026; primary completion for Jan 2033, 84 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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