The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery
Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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;
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- UZ Brussel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient undergoing thoracic surgery for a confirmed or suspected lung cancer
Exclusion Criteria:
- Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
- ASA ≥ 3
- Bleeding disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Costal bone marrow aspiration
4 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo
Time Frame: 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
|
7 days following surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the Amount of HPSC's That Can be Obtained From Costal Bone Marrow
Time Frame: 7 days following aspiration from the 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UZB-DVH-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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