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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:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Health-related Quality of Life | Assesment of Health-related quality of life in lung cancer patients undergoing treatment | 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. | Up to 10 years after treatment |
| Readmission | Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression. | 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]). | Up to 10 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Helena M Verkooijen, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | 3508GA | Netherlands |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |