NCT06996249

Brief 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. 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:

  1. 1.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.
  2. 2.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.
  3. 3.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.
  4. 4.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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Aug 2025Jan 2030

First Submitted

Initial submission to the registry

May 19, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

3.4 years

First QC Date

May 19, 2025

Last Update Submit

July 6, 2026

Conditions

Keywords

Dutch lung cancer cohortlung cancer cohort

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    up to 10 years

Secondary Outcomes (5)

  • Disease free survival

    up to 10 years

  • Overall survival

    up to 10 years

  • Health related quality of life

    Baseline - 3 - 6 - 12 - 24 - 36 - ... months

  • Health related quality of life

    Baseline - 3 - 6 - 12 - 24 - 36 - ... months

  • Health related quality of life

    Baseline - 3 - 6 - 12 - 24 - 36 - ... months

Study Arms (1)

Patients diagnosed with a thoracic malignancy

Patients diagnosed with thoracic malignancies will be asked to participate in this cohort.

Behavioral: Health-related quality of life and treatment outcome questionnairesGenetic: (Tumor) tissue and other biomaterialsProcedure: Blood samples

Interventions

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.

Patients diagnosed with a thoracic malignancy

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.

Patients diagnosed with a thoracic malignancy
Blood samplesPROCEDURE

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).

Patients diagnosed with a thoracic malignancy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Ziekenhuis Gelderse Vallei

Ede, Gelderland, 6716 RP, Netherlands

RECRUITING

Máxima MC

Eindhoven, North Brabant, 5504 DB, Netherlands

RECRUITING

Tergooi MC

Hilversum, Utrecht, 1212 VG, Netherlands

RECRUITING

Diakonessenhuis

Utrecht, Utrecht, 3582 KE, Netherlands

RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, 1815 JD, Netherlands

NOT YET RECRUITING

Meander MC

Amersfoort, 3813TZ, Netherlands

RECRUITING

NKI-AvL

Amsterdam, 1066 CX, Netherlands

NOT YET RECRUITING

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

NOT YET RECRUITING

Reinier de Graaf Gasthuis

Delft, 2625 AD, Netherlands

NOT YET RECRUITING

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

NOT YET RECRUITING

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

NOT YET RECRUITING

Groene Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

NOT YET RECRUITING

UMCG

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

Spaarne Gasthuis

Hoofddorp, 2134 TM, Netherlands

NOT YET RECRUITING

Frisius MC

Leeuwarden, 8934 AD, Netherlands

NOT YET RECRUITING

MUMC+

Maastricht, 6229HX, Netherlands

RECRUITING

Radboudumc

Nijmegen, 6525 GA, Netherlands

NOT YET RECRUITING

CWZ (Canisius Wilhelmina Ziekenhuis)

Nijmegen, 6532SZ, Netherlands

RECRUITING

Erasmus MC

Rotterdam, 3015GD, Netherlands

RECRUITING

Zuyderland

Sittard, 6162 BG, Netherlands

RECRUITING

Haga Ziekenhuis

The Hague, 2545 AA, Netherlands

NOT YET RECRUITING

st. Antonius Ziekenhuis

Utrecht, 3543 AZ, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor tissue will be stored.

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinomaCarcinoma, Squamous CellThymus NeoplasmsMesothelioma

Interventions

Quality of LifeTumor BurdenHistocompatibility TestingBlood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous CellLymphatic DiseasesHemic and Lymphatic DiseasesAdenomaNeoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthBody Weights and MeasuresAnthropometryInvestigative TechniquesImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImmunologic TechniquesSpecimen HandlingPuncturesSurgical Procedures, Operative

Study Officials

  • W.K. de Jong, Dr.

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

F.T.A. van der Velde

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
50 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 30, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations