Clinical trial NCT05145244: Copenhagen Master Observational Trial
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Breast Cancer
Keywords: Real world data
Observational trial
WGS, whole genome sequencing
Patient Reported Outcomes, PRO
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Detailed description: To date, there have been few studies evaluating the day- to-day effects of non-small cell lung cancer (NSCLC), and advanced (ABC) or metastatic breast cancer (mBC) and its treatment on patients in a real-world setting. There is a gap between the data from the narrowly focused low-quantity, high-quality interventional studies and less granular data collection, high-quantity real world data (RWD). Therefore, prospective, observational trials including all patients independent of biomarkers and collecting comprehensive data on each are needed.

Research question and objectives:

* To describe treatment outcomes based on RWD by a complete set of clinical, socio-psychological, medico-economics data and biospecimens, including whole genome sequencing (WGS) of all patients with breast cancer and NSCLC.
* To record the treatment-related adverse events and late effects experienced by patients based on PRO tools.
* To perform refined biomarker analyses, including (but not limited to) whole genome sequencing, on tumor biopsies at baseline and at progression, in order to identify potential treatment targets.

Study design: Prospective, non-interventional, multicenter study of patients initiating treatment for NSCLC or breast cancer in Copenhagen (Denmark).

Population: Eligible patients will have breast cancer or NSCLC and acceptable performance status and organ function.

Data sources: Study data will be collected via a baseline site questionnaire; Patient Reported Outcomes (PRO) questions via mobile application at cycle-based intervals; and patient medical information from medical records into an eCRF at baseline and at every visit until the end of the follow-up period. Baseline WGS will be performed on diagnostic/surgical specimens after informed consent according to the Danish law of the National Genome Center. There are no specific protocol-mandated tests, procedures, or clinic visits for this study, but repeat sequential biopsies for WGS are optional at progression. All data collection for this study will occur over a 30-months period (including all treatment lines for new patients included in the period).

Study size: Up to 2400 patients diagnosed with NSCLC or breast cancer will be enrolled. Breast cancer patients will be enrolled at Rigshospitalet, and NSCLC at Rigshospitalet and Herlev Hospital. Any patient who meets the eligibility criteria will be invited to participate in the study. Eligibility will be assessed prior to enrollment during a scheduled visit.

Data analysis: Analyses will generally be descriptive and explorative in nature and will be conducted using SPSS statistical software, and no sample size calculations can be performed. All variables will be summarized descriptively through tabular displays of mean, median, ranges, and standard deviations of continuous variables and frequency distributions of categorical variables. Exploratory analyses may be conducted to examine correlations and/or other research questions (e.g., time-to-first-neutropenia using Kaplan- Meier methods or mutational status and response). No formal hypothesis testing or comparisons between treatment groups are performed.

Eligibility criteria: 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 outcomes:
measure: Progression free survival
timeFrame: 3 years
measure: Patient reported outcomes
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Treatment response
timeFrame: 3 years
measure: Adverse events
timeFrame: 3 years
measure: Late effects
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References: