Copenhagen Master Observational Program
Official title: Copenhagen Master Observational Trial (C-MOT): A Prospective Investigator-initiated Observational Study to Study Biomarkers in Relation to Clinical Outcome in Patients With Non-Small Cell Lung Cancer or Breast Cancer
Run by Copenhagen University Hospital, Rigshospitalet · NCT05145244 · Data updated 2026-11-12
This project will collect clinical data, patient-reported outcomes, and whole-genome sequencing to see how treatments affect adults with non-small cell lung cancer or breast cancer treated in Copenhagen.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2400 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT05145244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with non-small cell lung cancer or breast cancer who are beginning medical or radiation therapy, can read Danish, provide informed consent, and agree to provide biospecimens and PRO data.
✕Probably not a fit
Patients starting adjuvant systemic therapy for breast cancer, those with life expectancy under three months, or those unable or unwilling to consent or provide samples may not benefit from the program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-interventional, multicenter observational program enrolling adults with NSCLC or breast cancer treated at Rigshospitalet in Copenhagen. It will collect detailed clinical, socio-psychological, and medico-economic data alongside patient-reported outcomes and biospecimens, including tumor biopsies for whole-genome sequencing at baseline and at progression. Participants receive standard-of-care or trial therapies while the study records treatment-related adverse events, late effects, and outcomes. Data will be used for refined biomarker analyses to link genomic findings with real-world treatment responses.
Why it matters
Potential benefit: If successful, the project could help tailor treatment decisions and identify new therapeutic targets by linking whole-genome data and real-world outcomes.
How similar studies have gone: Previous real-world genomic and PRO initiatives have generated useful biomarker–outcome correlations, but comprehensive prospective WGS across all-comer NSCLC and breast cancer populations is still relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients (≥ 18 years of age) with diagnosis of NSCLC or breast cancer amenable to medical or radiation therapy with curative or palliative intent * Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study * Able to read and understand Danish * Willing and able to complete collection of data including WGS Exclusion Criteria: * Patient with breast cancer initiating adjuvant systemic therapy * In the judgment of the investigator, the patient's life expectancy is fewer than 3 months at the time of diagnosis of NSCLC or breast cancer
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Ulrik Lassen, MD
- Email: ulrik.lassen@regionh.dk
- Phone: +4535453545
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.