Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer Metastatic
- Sponsor
- iOMEDICO AG
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality).
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The registry aims to collect and analyse information on the antineoplastic treatment of patients with metastatic colorectal cancer, treated in palliative intention in daily routine practice in Germany.
Detailed Description
AZURITE is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of metastatic colorectal cancer in Germany. The registry will follow patients for up to three years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life (HRQoL) will be evaluated for up to three years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically proven metastatic colorectal cancer (stage IV) at time of inclusion (patients with metastatic disease and potential curative treatment intention are allowed)
- •Age ≥ 18 years
- •Planned first systemic therapy for metastatic disease
- •Signed and dated informed consent form
- •Patients participating in the PRO module: prior to or at start of first systemic treatment for mCRC
- •Patients not participating in the PRO module: within four weeks after start of fist systemic therapy for mCRC
Exclusion Criteria
- •Patient who do not receive any systemic therapy for mCRC
- •Patients whose metastatic disease was surgically resected prior to inclusion and who start adjuvant chemotherapy
Outcomes
Primary Outcomes
Course of treatment (treatment reality).
Time Frame: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
Secondary Outcomes
- Progression-free survival.(3 years per patient.)
- Overall survival.(3 years per patient.)
- Carcinoma Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)
- Best Response.(3 years per patient.)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient.)