Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-19 @ 10:51 PM
Study NCT ID:
NCT05069792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
Sponsor:
UMC Utrecht
Organization:
Study Overview
Official Title:
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
U-COLOR
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: