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Recruiting Observational

Copenhagen Master Observational Trial

NCT05145244 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2021-08-01
Last updated
2026-08-12

Condition(s) studied

Non-small Cell Lung CancerBreast Cancer

Investigational drug(s) / intervention(s)

No Intervention: Observational Cohort

No Intervention: Observational Cohort: No intervention

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Progression free survival — 3 years
    Time from baseline to progression (measured using RECIST v1.1)
  • Patient reported outcomes — 3 years
    Health related quality of life. Two istruments will be used: EQ-5D-5L and EORTC QLQ-C30. The EQ-5D-5L will be administered at baseline and after each chemo cycle. The EORTC QLQ-C30 will be administered at baseline and 3 months after baseline.

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05145244 on ClinicalTrials.gov ↗ ← All trials in Denmark