An observational study in Lung Cancer, sponsored by UMC Utrecht. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by UMC Utrecht · Observational
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.
The prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), aims to:
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who are referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht for treatment of lung cancer will be eligible to be enrolled in the U-COLOR cohort.
Exclusion Criteria:
Change in Health-related Quality of Life
Assesment of Health-related quality of life in lung cancer patients undergoing treatment
Time frame: Up to 10 years after treatment
Occurence of toxicity (adverse events)
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.
Time frame: Up to 10 years after treatment
Readmission
Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
Time frame: Up to 10 years after treatment
Survival
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 \[in Dutch: Integraal Kankercentrum Nederland, IKNL\]).
Time frame: Up to 10 years after treatment
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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UMC Utrecht