No Intervention: Observational Cohort / Breast Cancer / Non Small Cell Lung Cancer · Observational Study

Copenhagen Master Observational Trial

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective, non-interventional observational cohort study registered to enroll approximately 2400 patients with non-small cell lung cancer or breast cancer and track progression-free survival and patient-reported outcomes over 3 years in relation to biomarkers including whole-genome sequencing. No results have been posted in this registry record; the study is currently recruiting.

What was studied

Observational. Non-small Cell Lung Cancer, Breast Cancer; age from 18 Years. Intervention: Patients with newly diagnosed non-small cell lung cancer; Patients with metastatic breast cancer. n = 2,400. 1 site: Denmark.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This observational study will describe real-world outcomes and biomarker associations in two common cancers, but results are not yet available. Clinicians should await publication of findings to inform use of whole-genome sequencing in routine oncology practice.

Plain-language summary

This is a prospective observational registry record with no reported results; it describes a planned study design and enrollment target only.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Progression free survival (assessed at 3 years); Patient reported outcomes (assessed at 3 years)

DesignObservational

PopulationNon-small Cell Lung Cancer, Breast Cancer; age from 18 Years

Sample size2,400

InterventionPatients with newly diagnosed non-small cell lung cancer; Patients with metastatic breast cancer

Setting1 site: Denmark

Reported figures

Quoted from the source exactly as published.

Planned sample size2400

Primary outcome measure 1Progression free survival, 3 years

Primary outcome measure 2Patient reported outcomes, 3 years

Study typeProspective non-interventional observational cohort

Clinical bottom line

Caveats

No results have been reported; this is a registry record only.
Study is actively recruiting and outcome data collection is ongoing.
No control or comparator arm; purely descriptive observational design.
Specific eligibility criteria, follow-up procedures, and biomarker analysis methods not detailed in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective non-interventional observational cohort; no control arm.

Directness

strong

Addresses clinical outcomes (progression-free survival, patient-reported outcomes) in real-world treatment.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

limited

Observational design without blinding or control; confounding and selection bias possible.

Sample adequacy

moderate

Estimated enrollment 2400 across two cancer types; adequate for descriptive outcomes.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05145244). This is a study registration, not published results. Lead sponsor: Rigshospitalet, Denmark. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 2400 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer, Breast Cancer. Interventions: OTHER: No Intervention: Observational Cohort. Primary outcome measures: Progression free survival , 3 years; Patient reported outcomes , 3 years. Brief summary: The primary objectives of this prospective non-interventional study (NIS) are to assess and describe outcomes in relation to biomarkers, including whole-genome sequencing (WGS) in patients with non- small cell lung cancer (NSCLC) or breast cancer receiving treatment offered in the clinic (standard of care or included in clinical trials).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05145244Rigshospitalet, DenmarkNo Intervention: Observational CohortBreast CancerNon Small Cell Lung Cancer