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

Lung Cancer Clinical Trial

— U-COLOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05069792
• Other study ID #: NL71047.041.19
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: July 2030

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: July 2030
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Readmission	Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.	Up to 10 years after treatment
Primary	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