Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
Study NCT ID:
NCT05251805
Status:
TERMINATED
Last Update Posted:
2025-06-08
First Post:
2022-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Study Overview
Official Title:
Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initial observations suggest challenges in performing bone marrow aspiration in the first few patients enrolled in the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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;
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: