Copenhagen Master Observational Trial (C-MOT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Non-small Cell Lung Cancer
• Intervention / Treatment: Other: NO intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 2400

Contacts and Locations

• Study Contact: Name: Ulrik Lassen, MD; Phone Number: +4535453545; Email: ulrik.lassen@regionh.dk
• Study Contact Backup: Name: Andreas Bjerrum, MD; Phone Number: +4535450966; Email: andreas.bjerrum@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Principal Investigator: Ulrik Lassen, MD, PH.D
    • Contact: Ulrik Lassen, MD; Phone Number: +4535453545; Email: ulrik.lassen@regionh.dk
    • Contact: Andreas Bjerrum, MD; Phone Number: +4535450966; Email: andreas.bjerrum@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from baseline to death or censoring	3 years
Treatment response	Treatment response will be measured using RECIST v1.1	3 years
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.	3 years
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.	3 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Real world data; Observational trial; WGS, whole genome sequencing; Patient Reported Outcomes, PRO
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: C-MOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No