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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05069792

Acronym

U-COLOR

Enrollment

2000

Registered

2021-10-06

Start date

2020-07-01

Completion date

2030-07-31

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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
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.
Readmission	Up to 10 years after treatment	Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
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 \[in Dutch: Integraal Kankercentrum Nederland, IKNL\]).

Countries

Netherlands

Outcome results