NCT05092009

Brief Summary

Extra tissue will be taken from patient during a procedure in standard of care. Also, through an existing line, 10ml of extra blood will be drawn. From this material the investigator will try to establish matched normal and primary human lung cancer organoids.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

3 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 Progress65%
Oct 2022Apr 2028

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

September 15, 2021

Last Update Submit

July 14, 2025

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Lung cancer organoids

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will: • the rate of proliferation and cell death (turnover) will be calculated

    1 year

  • Lung cancer organoids

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will: • the size distribution of the organoids

    1 year

  • Lung cancer organoids

    Establishing matched normal and primary human lung cancer organoids from patient-derived (tumor) tissue material by establishing long term culturing and bio-banking conditions for matched normal and primary lung cancer organoids from patient-derived lung (tumor) material. From these, we will In the established organoids we will: • determine the frequency of primary, secondary and tertiary organoid formation

    1 year

Secondary Outcomes (12)

  • Oncogenetic drivers

    1 year

  • Tumor heterogeneity

    1 year

  • Molecular biology

    1 year

  • Treatment response

    1 year

  • Xenografts

    1 year

  • +7 more secondary outcomes

Study Arms (1)

All patiens

There is only one arm in this trial

Other: Tissue and blood

Interventions

Tissue and bloodOTHER

Tissue and blood will be derived from patient during a standard of care procedure

All patiens

Eligibility Criteria

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

Patients with lung cancer

You may qualify if:

  • All patients selected to undergo primary surgical resection of a primary lung cancer. All types of resection are eligible, e.g. wedge resection, segmental resection, lobectomy, pneumonectomy.
  • All patients with (suspected) lung cancer that will undergo a bronchoscopy or endobronchial ultrasound guided transbronchial needle aspiration (EBUS/EUS-TBNA) bronchoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Zuyderland Medical Center

Heerlen, 6419 PC, Netherlands

RECRUITING

Maastricht Radiation Oncology (Maastro)

Maastricht, 6229 ET, Netherlands

NOT YET RECRUITING

MUMC+

Maastricht, 6229 HX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumour tissue

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Histocompatibility TestingBlood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesSpecimen HandlingPuncturesSurgical Procedures, Operative

Central Study Contacts

Chantal Overhof, BEc.

CONTACT

+31 88 44 55 863chantal.overhof@maastro.nl

Ann Claessens

CONTACT

+31 88 44 55 863ann.claessens@maastro.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 25, 2021

Study Start

October 5, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2028

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)