An interventional study of Blood, bone marrow and lung tumor tissue collection in Non Small Cell Lung Cancer, sponsored by Universitair Ziekenhuis Brussel. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Basic science
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.
This pilot trial is designed to evaluate the feasibility and safety of obtaining bone marrow from costal aspiration during surgery.
Previous trials demonstrated the feasibility of micro-metastasis detection in rib marrow aspirate. This procedure appears safe since no adverse events were documented during previous trials. The investigators hypothesize this technique can be used to obtain sufficient bone marrow-derived HSPC's (which represent only 0,1% of the total bone marrow fraction) 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. The use of rib marrow eliminates the need for extra incisions because the cuts made for trocar placement or the thoracotomy can be re-used. Therefore, the investigators hypothesize that the patients undergoing costal bone marrow aspiration during surgery will not experience extra discomfort. Every patient undergoing thoracic surgery is treated according to ERAS protocols with a major emphasis on pain control.
If the feasibility and safety of bone marrow aspiration are confirmed by this pilot trial, the investigators plan to conduct a large-scale study in which they will collect and bank blood, bone marrow and tumor per NSCLC patient. With this unique autologous biological material collection, the investigators aspire to conduct innovative research into the current resistance mechanisms of NSCLC to immunotherapy;
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 4 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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Exclusion Criteria:
4 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected
Procedure: Blood, bone marrow and lung tumor tissue collection
Blood sampling: 12ml of blood will be collected during the routine pre-operative blood collection Bone marrow aspiration during thoracic surgery: following the surgical intervention, bone marrow aspiration will be performed through the incisions made for the thoracic procedure. The ribs lying directly above and below the trocar incision will be exposed. A bone marrow needle will be advanced into the periost until the needle tip reaches the bone marrow. After removing the stylet a 2ml syringe will be attached to the aspiration needle and 0.5ml to 2ml of bone marrow will be aspirated before removing the needle. This procedure will be repeated twice for every trocar site, for a maximum of 3 trocar sites, or until 5ml of bone marrow aspirate is obtained. Lung tumor collection: all surgical samples will be analyzed by our anatomopathological department. Viable and fresh material, not used for the diagnostic purposes, will be sent to the LMCT.
The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo
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
Time frame: 7 days following surgery
Measurement of the Amount of HPSC's That Can be Obtained From Costal Bone Marrow
a minimum of 2x106 Lin- CD34+ HPSC are required to allow single cell sequencing, 3D bone marrow cultivation and transplantation in immunodeficient mice.
Time frame: 7 days following aspiration from the bone marrow
| Milestone | Costal Bone Marrow Aspiration |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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
| total of adverse events | Costal Bone Marrow Aspiration |
|---|---|
| The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo | 6 (2 to 11) |
a minimum of 2x106 Lin- CD34+ HPSC are required to allow single cell sequencing, 3D bone marrow cultivation and transplantation in immunodeficient mice.
No measurements were reported for this outcome.
Collected over all adverse events were captured from signing the ICF till 30 days post surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Costal Bone Marrow Aspiration | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Event | Costal Bone Marrow Aspiration |
|---|---|
| NauseaGastrointestinal disorders | 3/4 |
| HypoxiaBlood and lymphatic system disorders | 2/4 |
| hypotensionBlood and lymphatic system disorders | 2/4 |
| stressGeneral disorders | 2/4 |
| injection site reactionInfections and infestations | 1/4 |
| hypokalemiaBlood and lymphatic system disorders | 1/4 |
| feverGeneral disorders | 1/4 |
| constipationGastrointestinal disorders | 1/4 |
| pneumothoraxRespiratory, thoracic and mediastinal disorders | 1/4 |
| phlebitisBlood and lymphatic system disorders | 1/4 |
| Age, Categorical(Participants) | Costal Bone Marrow Aspiration |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | Costal Bone Marrow Aspiration |
|---|---|
| Female | 4 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Costal Bone Marrow Aspiration |
|---|
| Region of Enrollment(participants) | Costal Bone Marrow Aspiration |
|---|---|
| Belgium | 4 |
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Carcinoma, Non-Small-Cell Lung→
Universitair Ziekenhuis Brussel