Clinical trial NCT05251805: The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery
Official title: Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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;

Eligibility criteria: 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

Primary outcomes:
measure: The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo
timeFrame: 7 days following surgery
Secondary outcomes:
measure: Measurement of the Amount of HPSC's That Can be Obtained From Costal Bone Marrow
timeFrame: 7 days following aspiration from the bone marrow
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
References: