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NCT05251805

The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery

Terminated NA Results posted Last updated 8 June 2025
What this trial tests

NA trial testing Blood, bone marrow and lung tumor tissue collection in Non Small Cell Lung Cancer in 4 participants. Terminated before completion.

Timeline
20 March 2023
Primary endpoint
22 July 2023
31 December 2024

Quick facts

Lead sponsorUniversitair Ziekenhuis Brussel
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment4
Start date20 March 2023
Primary completion22 July 2023
Estimated completion31 December 2024
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universitair Ziekenhuis Brussel — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo Primary · 7 days following surgery

All adverse events will be classified by the Clavien Dindo classification. The study will be closed prematurely if 2 patients experience a grade 3 adverse event directly related to the bone marrow aspiration

GroupValue95% CI
Costal Bone Marrow Aspiration62 – 11

Adverse events — posted to ClinicalTrials.gov

Time frame: all adverse events were captured from signing the ICF till 30 days post surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Costal Bone Marrow Aspiration
Serious: 0/4 (0%)
Deaths: 0/4
Other adverse events (13 terms — click to expand)

ReactionSystemCostal Bone Marrow Aspirat…
NauseaGastrointestinal disorders
HypoxiaBlood and lymphatic system disorders
hypotensionBlood and lymphatic system disorders
stressGeneral disorders
injection site reactionInfections and infestations
hypokalemiaBlood and lymphatic system disorders
feverGeneral disorders
constipationGastrointestinal disorders
pneumothoraxRespiratory, thoracic and mediastinal disorders
phlebitisBlood and lymphatic system disorders
itchy backGeneral disorders
sleeplessnessGeneral disorders
stomach acheGastrointestinal disorders

Data from ClinicalTrials.gov NCT05251805 adverse events section.

Sponsor's own description

This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery. The investigators hypothese that sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) can be derived by rib bone marrow aspiration for ex vivo single-cell evaluation, optimization of a 3D BMN platform and preclinical ex/in vivo assessment in patient-derived organoids and murine xenograft models.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The application of patient-derived organoid in the research of lung cancer.
    Li Y, Gao X, Ni C, Zhao B, et al · · 2023 · cited 29× · PMID 36696006 · DOI 10.1007/s13402-023-00771-3
  2. Patient-Derived Ex Vivo Cultures and Endpoint Assays with Surrogate Biomarkers in Functional Testing for Prediction of Therapeutic Response.
    Tsukamoto Y, Hirashita Y, Shibata T, Fumoto S, et al · · 2023 · cited 3× · PMID 37627132 · DOI 10.3390/cancers15164104

Verify or expand the search:

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

Other Universitair Ziekenhuis Brussel trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05251805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing