Lung CancerU-COLORNCT05069792
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
An observational study of Lung Cancer, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2020to Jul 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years;
- Radiographic and/or histologic proof of lung cancer;
- Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-related Quality of Life
Assesment of Health-related quality of life in lung cancer patients undergoing treatment
Measured: 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.
Measured: Up to 10 years after treatment
Readmission
Reintervention (re-irradiation, surgery, other), tube feeding requirement or treatment for local and/or distant progression.
Measured: 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]).
Measured: Up to 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Jul 2020
- Primary completionDec 2024 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M Verkooijen, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069792
- Sponsor's protocol ID
- NL71047.041.19
- Acronym
- U-COLOR
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)
- ClinicalTrials.gov ID
- NCT05069792
- Acronym / sponsor ID
- U-COLOR / NL71047.041.19
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Radiographic and/or histologic proof of lung cancer;
- Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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]).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena M Verkooijen, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-related Quality of Life (time frame: Up to 10 years after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.