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Active, Not Recruiting

NCT Number: NCT04867525

Registry Platform Colorectal Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple sites all over germany

Multiple Locations, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician's choice according to patient's needs.

Other

Routine care as per site standard.

Primary outcomes

  1. Course of treatment (treatment reality).

    Time frame: 3 years per patient.

    Documentation of anamnestic data and therapy sequences.

Secondary outcomes

  1. Best Response.

    Time frame: 3 years per patient.

    Documentation of response rates per line of treatment.

  2. Progression-free survival.

    Time frame: 3 years per patient.

    Documentation of progression-free survival per line of treatment.

  3. Overall survival.

    Time frame: 3 years per patient.

    Documentation of overall survival per line of treatment.

  4. 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].

  5. 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].

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: AZURITE

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
Apr 30, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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