Non Small Cell Lung CancerNCT05251805
The Safety and Feasibility of Costal Bone Marrow Aspiration During Thoracic Surgery
A study testing Blood, bone marrow and lung tumor tissue collection in people with Non Small Cell Lung Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Blood, bone marrow and lung tumor tissue collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing thoracic surgery for a confirmed or suspected lung cancer
Who cannot join
- Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
- ASA ≥ 3
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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;
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Blood, bone marrow and lung tumor tissue collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, bone marrow and lung tumor tissue collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Costal bone marrow aspiration | Experimental | 4 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected Receives: Procedure: Blood, bone marrow and lung tumor tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days following surgery
Secondary outcomes (1)
Measurement of the Amount of HPSC's That Can be Obtained From Costal 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.
Measured: 7 days following aspiration from the bone marrow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start20 Mar 2023
- Primary completion22 Jul 2023
- Study completion31 Dec 2024
Why it stopped: Initial observations suggest challenges in performing bone marrow aspiration in the first few patients enrolled in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251805
- Sponsor's protocol ID
- UZB-DVH-2022-01
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2022
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial Evaluating the Safety and Feasibility of Bone Marrow Aspiration From Ribs During Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05251805
- Acronym / sponsor ID
- UZB-DVH-2022-01
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial observations suggest challenges in performing bone marrow aspiration in the first few patients enrolled in the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Costal bone marrow aspiration | Experimental | Procedure: Blood, bone marrow and lung tumor tissue collection4 NSCLC patients undergoing surgery from which blood samples, bone marrow aspirate and lung tumor tissue will be collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing thoracic surgery for a confirmed or suspected lung cancer
Key exclusion criteria (3 listed)
- Uncertainty of pre-operative diagnosis, exception is per-op frozen section analysis confirming malignity
- ASA ≥ 3
- Bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood, bone marrow and lung tumor tissue collectionBlood 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. | Procedure or surgery | Costal bone marrow aspiration |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, bone marrow and lung tumor tissue collection in people with Non Small Cell Lung Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence of Adverse Events Following Costal Bone Marrow Aspiration Classified by Calvien Dindo (time frame: 7 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.