Registry Platform Colorectal Cancer

Active, not recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Other: Physician's choice according to patient's needs.

• Registration Number: NCT04867525
• Lead Sponsor: iOMEDICO AG

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2021-05-01
• Primary Completion: 2022-04-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer Metastatic	Physician's choice according to patient's needs.	-

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality).	3 years per patient.	Documentation of anamnestic data and therapy sequences.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Multiple sites all over germany; 🇩🇪 Multiple Locations, Germany