Clinical trial NCT04867525: Registry Platform Colorectal Cancer
Official title: Clinical Research Platform for Molecular Testing, Treatment, Quality of Life and Outcome of Patients With Metastatic Colorectal Cancer Receiving Systemic Therapy (AZURITE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer Metastatic
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with metastatic (stage IV) colorectal cancer requiring palliative systemic first-line therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Course of treatment (treatment reality).
timeFrame: 3 years per patient.
Secondary outcomes:
measure: Best Response.
timeFrame: 3 years per patient.
measure: Progression-free survival.
timeFrame: 3 years per patient.
measure: Overall survival.
timeFrame: 3 years per patient.
measure: Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient.
measure: Carcinoma Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient.
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over germany
Study officials:
affiliation: Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
name: Nicolas Graf, PD Dr.
role: STUDY_CHAIR
affiliation: Weiden i.d.O.
name: Frank Kullmann, Prof. Dr.
role: STUDY_CHAIR
affiliation: München
name: Marlies Michl, PD Dr.
role: STUDY_CHAIR
affiliation: München
name: Jens Neumann, Prof. Dr.
role: STUDY_CHAIR
affiliation: Frechen
name: Roland Schnell, PD Dr.
role: STUDY_CHAIR
affiliation: Berlin
name: Sebastian Stintzing, Prof. Dr.
role: STUDY_CHAIR
affiliation: Freiburg i. Br.
name: Karin Potthoff, Dr.
role: STUDY_CHAIR
References: