Copenhagen Master Observational Trial

NCT05145244 | Recruiting FDA Drug

• 1 other identifier: C-MOT
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer; Breast Cancer

Keywords

Real world data; Observational trial; WGS, whole genome sequencing; Patient Reported Outcomes, PRO

Outcome Measures

Primary Outcomes (2)

• Progression free survival

  Time from baseline to progression (measured using RECIST v1.1)

  3 years

• Patient reported outcomes

  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.

  3 years

Secondary Outcomes (4)

• Overall survival

  3 years

• Treatment response

  3 years

• Adverse events

  3 years

• Late effects

  3 years

Study Arms (2)

Patients with newly diagnosed non-small cell lung cancer

Approximately 1800 patients who are initiating * Standard of care, including targeted therapy based on PD-L1 status, EGFR, ALK or ROS1 (routine biomarkers) * Active clinical trials in the clinics after informed consent

Other: NO intervention

Patients with metastatic breast cancer

Approximately 600 patients who are initiating * Standard of care, including targeted therapy based on HER2 status and ER status (routine biomarkers) * Active clinical trials in the clinics after informed consent

Other: NO intervention

Interventions

NO intervention OTHER

No intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will have non-small cell lung cancer or breast cancer and acceptable performance and organ function

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Diagnostic specimens will be used as baseline, and new biopsies will be performed at progression if feasible. A fresh tumor sample from metastatic sites will be obtained under local anaesthesia. If adequate tissue is available, samples are stored in RNAlater (Life Technologies) for RNA expression analyses and DNA gene mutation analyses and one sample is being formalin-fixed, paraffin-embedded (FFPE) for histopathologic analyses. Otherwise, formalin-fixed, paraffin-embedded (FFPE) will be used for WGS. A blood sample (7 mL EDTA) is collected for germline mutation analysis. Liquid biopsies will be performed at baseline and at every treatment cycle. Peripheral blood is collected in BCT tubes (Streck Laboratories, Omaha, NE, USA). Circulating DNA (cfDNA) will be extracted from 2-4 ml plasma using the QIAsymphony Circulating DNA Kit (Qiagen, Hilden, Germany).

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ulrik Lassen, MD

CONTACT

+4535453545; ulrik.lassen@regionh.dk

Andreas Bjerrum, MD

CONTACT

+4535450966; andreas.bjerrum@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 6, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

DK (1)