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

NCT05251805 | Terminated Results

• 1 other identifier: UZB-DVH-2022-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Measurement of the Amount of HPSC's That Can be Obtained From Costal Bone Marrow

  7 days following aspiration from the bone marrow

Study Arms (1)

Costal bone marrow aspiration

EXPERIMENTAL

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

Interventions

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.

Costal bone marrow aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing thoracic surgery for a confirmed or suspected lung cancer

You may not qualify if:

• Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
• ASA ≥ 3
• Bleeding disorders

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Head of the anesthesiology department
• Organization: UZ Brussel

anesthesiology.clinicaltrials@uzbrussel.be

024776001

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 23, 2022
• Study Start: March 20, 2023
• Primary Completion: July 22, 2023
• Study Completion: December 31, 2024
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)