Colorectal Cancer MetastaticAZURITENCT04867525
Registry Platform Colorectal Cancer
An observational study of Colorectal Cancer Metastatic, run by iOMEDICO AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Physician's choice according to patient's needs.
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2021to Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with metastatic (stage IV) colorectal cancer requiring palliative systemic first-line therapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Physician's choice according to patient's needs.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician's choice according to patient's needs.Other
Routine care as per site standard.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Metastatic | Not described Receives: Other: Physician's choice according to patient's needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of treatment (treatment reality).
Documentation of anamnestic data and therapy sequences.
Measured: 3 years per patient.
Secondary outcomes (5)
Best Response.
Documentation of response rates per line of treatment.
Measured: 3 years per patient.
Progression-free survival.
Documentation of progression-free survival per line of treatment.
Measured: 3 years per patient.
Overall survival.
Documentation of overall survival per line of treatment.
Measured: 3 years per patient.
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].
Measured: 3 years per patient.
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].
Measured: 3 years per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 May 2021
- Primary completion4 Apr 2022
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Graf, PD Dr., Study chair, Deggendorf Institute of Technology, Faculty of Applied Healthcare SciencesFrank Kullmann, Prof. Dr., Study chair, Weiden i.d.O.Marlies Michl, PD Dr., Study chair, MünchenJens Neumann, Prof. Dr., Study chair, MünchenRoland Schnell, PD Dr., Study chair, FrechenSebastian Stintzing, Prof. Dr., Study chair, BerlinKarin Potthoff, Dr., Study chair, Freiburg i. Br.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867525
- Sponsor's protocol ID
- IOM-100452
- Acronym
- AZURITE
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)
- ClinicalTrials.gov ID
- NCT04867525
- Acronym / sponsor ID
- AZURITE / IOM-100452
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Metastatic | – | Other: Physician's choice according to patient's needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with metastatic (stage IV) colorectal cancer requiring palliative systemic first-line therapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician's choice according to patient's needs.Routine care as per site standard. | Other | Colorectal Cancer Metastatic |
Primary outcome
Course of treatment (treatment reality).
Time frame: 3 years per patient.
Documentation of anamnestic data and therapy sequences.
5 secondary outcomes
Best Response.
Time frame: 3 years per patient.
Progression-free survival.
Time frame: 3 years per patient.
Overall survival.
Time frame: 3 years per patient.
Health-related quality of life (Patient-reported outcome, PRO).
Time frame: 3 years per patient.
Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
Time frame: 3 years per patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Graf, PD Dr. study chair
Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
Frank Kullmann, Prof. Dr. study chair
Weiden i.d.O.
Marlies Michl, PD Dr. study chair
München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of treatment (treatment reality). (time frame: 3 years per patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.