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

Not Applicable

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Procedure: Blood, bone marrow and lung tumor tissue collection

• Registration Number: NCT05251805
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-23
• Study Start: 2023-03-20
• Primary Completion: 2023-07-22
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Costal bone marrow aspiration	Blood, bone marrow and lung tumor tissue collection	10 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected

Primary Outcome Measures

Name	Time	Method
The occurrence of adverse events following costal bone marrow aspiration classified by Calvien Dindo	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

Secondary Outcome Measures

Name	Time	Method
Measurement of the amount of HPSC's that can be obtained from costal bone marrow	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.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussels, Belgium