Registry Platform Colorectal Cancer (AZURITE)

April 29, 2025 updated by: iOMEDICO AG

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Multiple Locations, Germany
        • Multiple sites all over Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with metastatic (stage IV) colorectal cancer requiring palliative systemic first-line therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal Cancer Metastatic
Other: Physician's choice according to patient's needs.
Routine care as per site standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of treatment (treatment reality).
Time Frame: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
3 years per patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Response.
Time Frame: 3 years per patient.
Documentation of response rates per line of treatment.
3 years per patient.
Progression-free survival.
Time Frame: 3 years per patient.
Documentation of progression-free survival per line of treatment.
3 years per patient.
Overall survival.
Time Frame: 3 years per patient.
Documentation of overall survival per line of treatment.
3 years per patient.
Health-related quality of life (Patient-reported outcome, PRO).
Time Frame: 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].
3 years per patient.
Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
Time Frame: 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].
3 years per patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Study Chair: Frank Kullmann, Prof. Dr., Weiden i.d.O.
  • Study Chair: Marlies Michl, PD Dr., München
  • Study Chair: Jens Neumann, Prof. Dr., München
  • Study Chair: Roland Schnell, PD Dr., Frechen
  • Study Chair: Sebastian Stintzing, Prof. Dr., Berlin
  • Study Chair: Karin Potthoff, Dr., Freiburg i. Br.
  • Study Chair: Nicolas Graf, PD Dr., Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

April 4, 2022

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-100452

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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