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

NCT05069792 | Active Not Recruiting DMC

• 1 other identifier: NL71047.041.19
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Readmission

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

  Up to 10 years after treatment

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht for treatment of lung cancer will be eligible to be enrolled in the U-COLOR cohort.

You may qualify if:

• Age ≥ 18 years;
• Radiographic and/or histologic proof of lung cancer;
• Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Helena M Verkooijen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 6, 2021
• Study Start: July 1, 2020
• Primary Completion: December 1, 2024
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

NL (1)