Breast Cancer Clinical Trial
— C-MOTOfficial 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
NCT number | NCT05145244 |
Other study ID # | C-MOT |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | December 31, 2023 |
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).
Status | Recruiting |
Enrollment | 2400 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival | Time from baseline to progression (measured using RECIST v1.1) | 3 years | |
Primary | 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 | Overall survival | Time from baseline to death or censoring | 3 years | |
Secondary | Treatment response | Treatment response will be measured using RECIST v1.1 | 3 years | |
Secondary | 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 | |
Secondary | 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 |
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