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Initial observations suggest challenges in performing bone marrow aspiration in the first few patients enrolled in the study.
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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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Costal bone marrow aspiration | Experimental | 4 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood, bone marrow and lung tumor tissue collection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days following aspiration from the bone marrow |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Costal Bone Marrow Aspiration | 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Costal Bone Marrow Aspiration | 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | total of adverse events | 7 days following surgery |
|
all adverse events were captured from signing the ICF till 30 days post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Costal Bone Marrow Aspiration | 10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of the anesthesiology department | UZ Brussel | 024776001 | +32 | anesthesiology.clinicaltrials@uzbrussel.be |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2023 | May 9, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | the HPSC's couldn't be measured as the bone marrow aspiration stayed unsuccesfull. hPSC's needed to be extracted from the costal bone marrow. However, since the bone marrow aspiration from the costal bone marrow stayed unsuccesfull, no hPSC's could be extracted and thus the amount could not be measured. | Posted | 7 days following aspiration from the bone marrow |
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| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| injection site reaction | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoxia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hypokalemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| hypotension | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| phlebitis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| itchy back | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| sleeplessness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| stomach ache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| stress | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |