Clinical trial · Observational
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Change in Health-related Quality of Life
- timeFrame
- Up to 10 years after treatment
- description
- Assesment of Health-related quality of life in lung cancer patients undergoing treatment
- measure
- Occurence of toxicity (adverse events)
- timeFrame
- Up to 10 years after treatment
- description
- 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.
- measure
- Readmission
- timeFrame
- Up to 10 years after treatment
- description
- Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available