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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Change in Health-related Quality of Life

Time frame: Up to 10 years after treatment

Assesment of Health-related quality of life in lung cancer patients undergoing treatment
Occurence of toxicity (adverse events)

Time frame: 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.
Readmission

Time frame: Up to 10 years after treatment

Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
Survival

Time frame: 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]).

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: U-COLOR

Important dates

Study start: 2020
Primary completion: 2024
Study completion: 2030
First posted: Oct 6, 2021
Registry last updated: Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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