Registry Platform Colorectal Cancer (AZURITE)

iOMEDICO

Status: Active, not recruiting

Conditions: Colorectal Cancer Metastatic

Treatments: Other: Physician's choice according to patient's needs.

Study type: Observational

Funder types: Industry

Identifiers

NCT04867525

IOM-100452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Colorectal Cancer Metastatic

Treatment:

Other: Physician's choice according to patient's needs.