Copenhagen Master Observational Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Eligible patients will have non-small cell lung cancer or breast cancer and acceptable performance and organ function
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: Patients with newly diagnosed non-small cell lung cancer1 intervention
Group B: Patients with metastatic breast cancer1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival
Time from baseline to progression (measured using RECIST v1.1)
Time frame
3 years2
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.
Time frame
3 yearsSecondary outcomes
1
Overall survival
Time from baseline to death or censoring
Time frame
3 years2
Treatment response
Treatment response will be measured using RECIST v1.1
Time frame
3 years3
Adverse events
Adverse events will be measured using a selection of instruments from the NCI PRO-CTCAE Measurement System (Danish version 1.0). For patients with lung cancer, the selection includes question #8, 9, 15, 16, 19, 20, 24, 46, 48, 52, 53, 54, 56 as well as free text entry. For patients with breast cancer, the selection includes question #8, 15, 39, 46, 48, 52, 53, 54, 56 as well as free text entry.
Time frame
3 years4
Late effects
Late effects will be measured using a selection of instruments from the NCI PRO-CTCAE Measurement System (Danish version 1.0). For patients with lung cancer, the selection includes question #8, 9, 15, 16, 19, 20, 24, 46, 48, 52, 53, 54, 56 as well as free text entry. For patients with breast cancer, the selection includes question #8, 15, 39, 46, 48, 52, 53, 54, 56 as well as free text entry.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov