Registry Platform Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— AZURITE  

Official title:

Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04867525
• Other study ID #: IOM-100452
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 2025
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Other:
• Physician's choice according to patient's needs.
Routine care as per site standard.

Locations

Country	Name	City	State
Germany	Multiple sites all over germany	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of treatment (treatment reality).	Documentation of anamnestic data and therapy sequences.	3 years per patient.
Secondary	Best Response.	Documentation of response rates per line of treatment.	3 years per patient.
Secondary	Progression-free survival.	Documentation of progression-free survival per line of treatment.	3 years per patient.
Secondary	Overall survival.	Documentation of overall survival per line of treatment.	3 years per patient.
Secondary	Health-related quality of life (Patient-reported outcome, PRO).	EORTC QLQ-C30 core questionnaire [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high scale score represents a higher response level: (a) global health status: a high score represents high quality of life, (b) functional scales: a high score represents high/healthy level of functioning, (c) symptom scales/items: a high score represents high level of symptomatology or problems].	3 years per patient.
Secondary	Carcinoma Health-related quality of life (Patient-reported outcome, PRO).	EORTC QLQ-CR29 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; Scale 0-100; a high score for scales and single items represents a high level of symptomatology or problems].	3 years per patient.