Registry Platform Colorectal Cancer

NCT04867525 | Active Not Recruiting

• 1 other identifier: IOM-100452
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Course of treatment (treatment reality).

  Documentation of anamnestic data and therapy sequences.

  3 years per patient.

Secondary Outcomes (5)

• Best Response.

  3 years per patient.

• Progression-free survival.

  3 years per patient.

• Overall survival.

  3 years per patient.

• Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient.

• Carcinoma Health-related quality of life (Patient-reported outcome, PRO).

  3 years per patient.

Study Arms (1)

Colorectal Cancer Metastatic

Other: Physician's choice according to patient's needs.

Interventions

Physician's choice according to patient's needs. OTHER

Routine care as per site standard.

Colorectal Cancer Metastatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient who do not receive any systemic therapy for mCRC

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Multiple sites all over germany

Multiple Locations, Germany

Location

Study Officials

• Nicolas Graf, PD Dr.

  Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: May 1, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

DE (1)