Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)

Active, not recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05069792
• Lead Sponsor: UMC Utrecht

Brief Summary

Objective: 1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions.

Study design: Observational, prospective cohort study, according to the 'TwiCs' design.

Study population: All patients with lung cancer referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht.

Main study parameters/endpoints: Clinical parameters (performance status, co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (toxicity, reintervention and survival), and patient-reported outcomes.

Detailed Description

The prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), aims to:

* Gather data on natural disease progression, treatment response, disease recurrence, complications, quality of life and survival of patients with lung cancer;

* Collect a patient group willing to participate in studies;

* Facilitate multiple, parallel randomized controlled trials within the cohort.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age ≥ 18 years;
• Radiographic and/or histologic proof of lung cancer;
• Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.

Exclusion Criteria

• Mental disorder or cognitive dysfunction that hinders the patient's ability to understand the informed consent procedure and/or study details;
• Patients with severe psychiatric disorders;
• Inability to understand the Dutch language.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of toxicity (adverse events)	Up to 10 years after treatment	Grade ≥3 side effects occurring during or up to 3 months after radiotherapy will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). For 'dysphagia' and 'pneumonitis' endpoints, also grade 2 toxicity will be scored.
Survival	Up to 10 years after treatment	Date of last follow-up, date of local progression, date of distant progression, location of distant progression. Overall survival (Survival of participating patients will be recorded using the follow up questionnaires \[returned by family members\] or are derived from the Statistic Netherlands Database \[in Dutch: Centraal Bureau voor de Statistiek, CBS\] and Dutch Cancer Registry \[in Dutch: Integraal Kankercentrum Nederland, IKNL\]).
Change in Health-related Quality of Life	Up to 10 years after treatment	Assesment of Health-related quality of life in lung cancer patients undergoing treatment
Readmission	Up to 10 years after treatment	Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands