Lung CancerDuTOCNCT06996249
Prospective Data Collection Initiative on Thoracic Malignancies
An observational study of Lung Cancer and Thoracic Cancer, run by Dutch Society of Physicians for Pulmonology and Tuberculosis at 23 sites in Netherlands.
Trial summary
Survival after cancer diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Thoracic Cancer, Lung Cancer, Nonsmall Cell
- What is being tested?
- Health-related quality of life and treatment outcome questionnaires, (Tumor) tissue and other biomaterials and Blood samples
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 12,000 participants
- Where
- 23 sitesNetherlands
- Study dates
- 15 Aug 2025to 1 Jan 2030
- How long will I take part?
- 50 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 diagnosed with a pathological confirmed thoracic malignancy, who are recently diagnosed, or have a strong suspicion without pathological confirmation but with confirmation in the multidisciplinary tumor board in one of the participating hospitals will be asked to participate in this cohort study.
Who may be able to join
- Age ≥ 18 years;
- Histo/cytopathological proof of a thoracic malignancy, or a strong suspicion (after imaging and multidisciplinary board);
- Informed consent for longitudinal observational data collection;
Who cannot join
- Mentally challenged patients that are unable to provide conscientious informed consent as determined by the investigator.
- Inability to provide a written or electronic informed consent.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Netherlands23 sites, 23 recruiting
- Not yet recruiting
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
- Recruiting
Meander MC
Amersfoort, 3813TZ
- Not yet recruiting
NKI-AvL
Amsterdam, 1066 CX
- Not yet recruiting
Amphia Ziekenhuis
Breda, 4818 CK
- Not yet recruiting
Reinier de Graaf Gasthuis
Delft, 2625 AD
- Not yet recruiting
Deventer Ziekenhuis
Deventer, 7416 SE
- Recruiting
Ziekenhuis Gelderse Vallei
Ede, Gelderland, 6716 RP
- Recruiting
Máxima MC
Eindhoven, North Brabant, 5504 DB
- Not yet recruiting
Medisch Spectrum Twente
Enschede, 7512 KZ
- Not yet recruiting
Groene Hart Ziekenhuis
Gouda, 2803 HH
- Not yet recruiting
UMCG
Groningen, 9713 GZ
- Recruiting
Tergooi MC
Hilversum, Utrecht, 1212 VG
- Not yet recruiting
Spaarne Gasthuis
Hoofddorp, 2134 TM
- Not yet recruiting
Frisius MC
Leeuwarden, 8934 AD
- Recruiting
MUMC+
Maastricht, 6229HX
- Not yet recruiting
Radboudumc
Nijmegen, 6525 GA
- Recruiting
CWZ (Canisius Wilhelmina Ziekenhuis)
Nijmegen, 6532SZ
- Recruiting
Erasmus MC
Rotterdam, 3015GD
- Recruiting
Zuyderland
Sittard, 6162 BG
- Not yet recruiting
Haga Ziekenhuis
The Hague, 2545 AA
- Recruiting
Diakonessenhuis
Utrecht, Utrecht, 3582 KE
- Recruiting
st. Antonius Ziekenhuis
Utrecht, 3543 AZ
- Recruiting
UMC Utrecht
Utrecht, 3584 CX
F.T.A. van der Velde
W.K. de Jong, Dr.
About this study
Official title: Prospective Data Collection Initiative on Thoracic Malignancies - a Prospective Observational Cohort Study
Survival after cancer diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of molecular factors, biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage. It is however still unclear which, how, and to what extent these factors will influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) thoracic malignancies such as lung cancer.
Although the results from prospective clinical trials will remain the backbone of evidence-based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of patients with cancer do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications:
Read more
- It is highly desirable to validate the results from clinical trials in the general patient population. This is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters.
- There is an ever increasing number of therapeutic interventions available for which its efficacy depends on known and unknown tumor-specific, clinical, demographic and other patient characteristics. Large numbers of patients are required to test the relevance of these variables.
- As a result of rapid technical and drug developments, new minimally invasive treatment options such as stereotactic irradiation or ablation techniques or sublobar resections and new targeted and immunotherapeutic treatments have entered the clinic. These interventions have potentially less side effects compared to the conventional treatments. Still, these new interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) in a real world setting.
- Many hypotheses related to further optimization of personalized medicine can currently not be tested as they require a large prospective cohort of patients, and a less time-consuming and costly research infrastructure.
A prospective observational cohort study has the potential to fill the gap between prospective randomized trials (efficacy) and patients treated in general practice (effectiveness) and it will enable accrual of clinical trials (innovation).
Read the detailed description
Objective:
- To start a prospective observational cohort study of patients with thoracic malignancies from their primary diagnosis until death.
- After obtaining informed consent, to prospectively collect data on medical history, comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and (S)AEs.
- After obtaining separate informed consent for collecting data on health related quality of life and work ability, to collect data on patient reported outcome measures.
- After obtaining separate informed consent, to collect imaging, blood and (tumor) tissue material, obtained during routine practice, for observational studies or storage in the biobank.
- After obtaining separate informed consent, to collect imaging obtained during routine practice, for observational studies or AI learning.
- The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new interventions (for example multidisciplinary anti-cancer treatment, drugs or other systemic treatment, lifestyle or in follow up) for patients with thoracic malignancies when appropriate according to the Trials within Cohorts (TwiCs) design. For interventions other than standard of care a separate informed consent is mandatory.
Expected outcome:
- To provide more accurate data on the treatment and clinical outcome and patient reported outcomes of thoracic malignancies in daily practice.
- To create an infrastructure for a large variety of research purposes including but not limited to:
- Prognostic and predictive research
- Molecular and (epi)genetic research
- Comparison of new therapeutic interventions for patients with thoracic malignancies, when appropriate according to the Trials within Cohorts (TwiCs) design.
- Health care policies and cost-effectiveness studies
Study design:
A prospective observational cohort study. Patients diagnosed with thoracic malignancies will be asked to participate in this cohort. Prospectively, a limited number of variables (e.g. gender, age, histology, TNM) will in the majority of cases preferably be registered within 1-3 weeks following diagnosis. Further enrichment of the data will be done by linking this cohort to the Netherlands Cancer Registry (NCR) database (in the Netherlands clinical variables, treatment variables of all malignancies are routinely collected (Appendix I)) on a 6 monthly basis.
- Conditions
- Lung Cancer, Thoracic Cancer, Lung Cancer, Nonsmall Cell, Adenocarcinoma, Squamous Cell Carcinoma, Large Cell Lung Cancer
- Being tested
- Health-related quality of life and treatment outcome questionnaires, (Tumor) tissue and other biomaterials, Blood samples
- Keywords
- Dutch lung cancer cohort, lung cancer cohort
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Squamous Cell, Thymus Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related quality of life and treatment outcome questionnairesBehavioural
Patients who consented to the completion of questionnaires will be invited to complete questionnaires on multiple time points but not more often than once every 3 months. The length of time required for the completion of questionnaires will not exceed 150 minutes a year.
(Tumor) tissue and other biomaterialsGenetic
Tissue and other biomaterial, such as pleural effusion, is collected from material obtained during a diagnostic procedure or surgical resection. No additional interventional procedures are performed to obtain the material.
Blood samplesProcedure or surgery
Blood samples can be withdrawn on multiple time points with a maximum of 10 tubes of 10 ml per year during routine blood withdrawals (or in exceptional cases with an additional blood withdrawal).
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with a thoracic malignancy | Patients diagnosed with thoracic malignancies will be asked to participate in this cohort. Receives: Behavioral: Health-related quality of life and treatment outcome questionnaires; Genetic: (Tumor) tissue and other biomaterials; Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: up to 10 years
Secondary outcomes (5)
Disease free survival
Measured: up to 10 years
Overall survival
Measured: up to 10 years
Health related quality of life
QLQc30 questionnaire with a 1 (not at all) to 4 (very much) scale
Measured: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
Health related quality of life
EQ5D questionnaire with a 1 (no problems) to 5 (not able to) scale and 0 (worst) to100 (best) measurement scale
Measured: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
Health related quality of life
LC-13 questionnaire with a 1 (not at all) to 4 (very much) scale
Measured: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start15 Aug 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 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.
- 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
- 12,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Dutch Society of Physicians for Pulmonology and Tuberculosis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W.K. de Jong, Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996249
- Sponsor's protocol ID
- Dutch Thoracic Oncology Cohort
- Other IDs
- NL-009157 / PI-01.01
- Acronym
- DuTOC
- Status last verified
- Jul 2026
- First submitted
- 19 May 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A research proposal can be submitted via DuTOC@umcutrecht.nl. A data and/or tissue requests for scientific research will be discussed and approved by a scientific committee. The scientific committee will discuss requests and the committee will subsequently decide regarding the handing out of the material and/or data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection Initiative on Thoracic Malignancies - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06996249
- Acronym / sponsor ID
- DuTOC / Dutch Thoracic Oncology Cohort
- Conditions
- Lung Cancer, Thoracic Cancer, Lung Cancer, Nonsmall Cell, Adenocarcinoma, Squamous Cell Carcinoma, Large Cell Lung Cancer
- Keywords
- Dutch lung cancer cohort, lung cancer cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Dutch Society of Physicians for Pulmonology and TuberculosisUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 30 May 2025 (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.
Survival after cancer diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of molecular factors, biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage. It is however still unclear which, how, and to what extent these factors will influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) thoracic malignancies such as lung cancer.
Although the results from prospective clinical trials will remain the backbone of evidence-based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of patients with cancer do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications:
- It is highly desirable to validate the results from clinical trials in the general patient population. This is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters.
- There is an ever increasing number of therapeutic interventions available for which its efficacy depends on known and unknown tumor-specific, clinical, demographic and other patient characteristics. Large numbers of patients are required to test the relevance of these variables.
- As a result of rapid technical and drug developments, new minimally invasive treatment options such as stereotactic irradiation or ablation techniques or sublobar resections and new targeted and immunotherapeutic treatments have entered the clinic. These interventions have potentially less side effects compared to the conventional treatments. Still, these new interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) in a real world setting.
- Many hypotheses related to further optimization of personalized medicine can currently not be tested as they require a large prospective cohort of patients, and a less time-consuming and costly research infrastructure.
A prospective observational cohort study has the potential to fill the gap between prospective randomized trials (efficacy) and patients treated in general practice (effectiveness) and it will enable accrual of clinical trials (innovation).
Detailed description
Objective:
- To start a prospective observational cohort study of patients with thoracic malignancies from their primary diagnosis until death.
- After obtaining informed consent, to prospectively collect data on medical history, comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and (S)AEs.
- After obtaining separate informed consent for collecting data on health related quality of life and work ability, to collect data on patient reported outcome measures.
- After obtaining separate informed consent, to collect imaging, blood and (tumor) tissue material, obtained during routine practice, for observational studies or storage in the biobank.
- After obtaining separate informed consent, to collect imaging obtained during routine practice, for observational studies or AI learning.
- The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new interventions (for example multidisciplinary anti-cancer treatment, drugs or other systemic treatment, lifestyle or in follow up) for patients with thoracic malignancies when appropriate according to the Trials within Cohorts (TwiCs) design. For interventions other than standard of care a separate informed consent is mandatory.
Expected outcome:
- To provide more accurate data on the treatment and clinical outcome and patient reported outcomes of thoracic malignancies in daily practice.
- To create an infrastructure for a large variety of research purposes including but not limited to:
- Prognostic and predictive research
- Molecular and (epi)genetic research
- Comparison of new therapeutic interventions for patients with thoracic malignancies, when appropriate according to the Trials within Cohorts (TwiCs) design.
- Health care policies and cost-effectiveness studies
Study design:
A prospective observational cohort study. Patients diagnosed with thoracic malignancies will be asked to participate in this cohort. Prospectively, a limited number of variables (e.g. gender, age, histology, TNM) will in the majority of cases preferably be registered within 1-3 weeks following diagnosis. Further enrichment of the data will be done by linking this cohort to the Netherlands Cancer Registry (NCR) database (in the Netherlands clinical variables, treatment variables of all malignancies are routinely collected (Appendix I)) on a 6 monthly basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with a thoracic malignancy | – | Behavioral: Health-related quality of life and treatment outcome questionnaires, Genetic: (Tumor) tissue and other biomaterials, Procedure: Blood samplesPatients diagnosed with thoracic malignancies will be asked to participate in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with a pathological confirmed thoracic malignancy, who are recently diagnosed, or have a strong suspicion without pathological confirmation but with confirmation in the multidisciplinary tumor board in one of the participating hospitals will be asked to participate in this cohort study.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Histo/cytopathological proof of a thoracic malignancy, or a strong suspicion (after imaging and multidisciplinary board);
- Informed consent for longitudinal observational data collection;
Key exclusion criteria (2 listed)
- Mentally challenged patients that are unable to provide conscientious informed consent as determined by the investigator.
- Inability to provide a written or electronic informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health-related quality of life and treatment outcome questionnairesPatients who consented to the completion of questionnaires will be invited to complete questionnaires on multiple time points but not more often than once every 3 months. The length of time required for the completion of questionnaires will not exceed 150 minutes a year. | Behavioural | Patients diagnosed with a thoracic malignancy |
| (Tumor) tissue and other biomaterialsTissue and other biomaterial, such as pleural effusion, is collected from material obtained during a diagnostic procedure or surgical resection. No additional interventional procedures are performed to obtain the material. | Genetic | Patients diagnosed with a thoracic malignancy |
| Blood samplesBlood samples can be withdrawn on multiple time points with a maximum of 10 tubes of 10 ml per year during routine blood withdrawals (or in exceptional cases with an additional blood withdrawal). | Procedure or surgery | Patients diagnosed with a thoracic malignancy |
Primary outcome
Progression free survival
Time frame: up to 10 years
5 secondary outcomes
Disease free survival
Time frame: up to 10 years
Overall survival
Time frame: up to 10 years
Health related quality of life
Time frame: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
Health related quality of life
Time frame: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
Health related quality of life
Time frame: Baseline - 3 - 6 - 12 - 24 - 36 - ... months
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 Jul 2026.
- DuTOC websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A research proposal can be submitted via DuTOC@umcutrecht.nl. A data and/or tissue requests for scientific research will be discussed and approved by a scientific committee. The scientific committee will discuss requests and the committee will subsequently decide regarding the handing out of the material and/or data.
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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.
W.K. de Jong, Dr. principal investigator
UMC Utrecht
23 sites 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 and Thoracic Cancer, run by Dutch Society of Physicians for Pulmonology and Tuberculosis at 23 sites 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 2 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Contact F.T.A. van der Velde (+31 6 296 86 985, dutoc@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 10 years). 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 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.