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
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Ulrik Lassen, MD
ulrik.lassen@regionh.dk
+4535453545
Backup
Andreas Bjerrum, MD
andreas.bjerrum@regionh.dk
+4535450966
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2400
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark