Circulating Tumor CellCTC-01NCT03645252
Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer
A study testing Vein interruption before any other surgical manipulation and Arteries interruption before vein interruption in people with Circulating Tumor Cell and Lung Cancer, run by Laval University at 1 site in Canada.
Trial summary
This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor Cell, Lung Cancer, Surgery
- What is being tested?
- Vein interruption before any other surgical manipulation and Arteries interruption before vein interruption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2018to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- NSCLC with preoperative pathological evidence,
- Pure solid nodule or part-solid (>50%) ground glass nodule on CT scan
- Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
- Video-assisted thoracoscopic lobectomy or bi-lobectomy
Who cannot join
- Pneumonectomy, segmentectomy, non anatomic resection
- History of thoracic surgery on the same side
- Necessity to perform a non-anatomic resection in addition to the lobectomy
- No preoperative histological diagnosis
- Pure ground glass nodule on CT scan
- Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion
Show all 12Show fewer
- Clinical stage node ≥1
- Neoadjuvant therapy
- Second cancer or cancer in the past 5 years
- First approach through thoracotomy with ribs spreading
- Pregnancy, <18 years of age
- Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V 4G5
Massimo Conti, MD, +14186568711 ext. 3853, massimo.conti@criucpq.ulaval.ca
Jérémy Tricard, MD
About this study
Official title: Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.
This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.
- Conditions
- Circulating Tumor Cell, Lung Cancer, Surgery
- Being tested
- Vein interruption before any other surgical manipulation, Arteries interruption before vein interruption
- Medical subject headings
- Neoplastic Cells, Circulating, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein interruption before any other surgical manipulationProcedure or surgery
The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).
In the "vein first" group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner.
Arteries interruption before vein interruptionProcedure or surgery
The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).
In the "arteries before vein" group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above.
| Study group | Role | What they receive |
|---|---|---|
| Vein first | Active comparator | Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation. Receives: Procedure: Vein interruption before any other surgical manipulation |
| Arteries before vein | Active comparator | Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein. Receives: Procedure: Arteries interruption before vein interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CTC density
Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Measured: Within 96 hours after surgery
Changes in CTC clusters density
Changes in CTC clusters (or CTC micro-emboli defined as ≥3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Measured: Within 96 hours after surgery
Secondary outcomes (2)
Disease free survival
Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis).
Measured: 2 years and 5 years after surgery
Overall survival
Overall survival 2 years and 5 years after surgery.
Measured: 2 years and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start31 Aug 2018 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circulating Tumor CellStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Responsible party
- Principal investigator, Massimo Conti, Laval University
- Investigators
- Massimo Conti, MD, Principal investigator, Centre de Recherche IUCPQ - Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645252
- Sponsor's protocol ID
- 2019-2997, 21621
- Acronym
- CTC-01
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crosbie PA, Shah R, Krysiak P, Zhou C, Morris K, Tugwood J, Booton R, Blackhall F, Dive C. Circulating Tumor Cells Detected in the Tumor-Draining Pulmonary Vein Are Associated with Disease Recurrence after Surgical Resection of NSCLC. J Thorac Oncol. 2016 Oct;11(10):1793-7. doi: 10.1016/j.jtho.2016.06.017. Epub 2016 Jul 25.
PubMed 27468936Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with primary lung cancer. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):775-83. doi: 10.1093/icvts/ivu048. Epub 2014 Mar 11.
PubMed 24618055
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT03645252
- Acronym / sponsor ID
- CTC-01 / 2019-2997, 21621
- Conditions
- Circulating Tumor Cell, Lung Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Study start
- 31 Aug 2018 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vein first | Active comparator | Procedure: Vein interruption before any other surgical manipulationTumor-draining pulmonary vein is interrupted first and before any surgical manipulation. |
| Arteries before vein | Active comparator | Procedure: Arteries interruption before vein interruptionLobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- NSCLC with preoperative pathological evidence,
- Pure solid nodule or part-solid (>50%) ground glass nodule on CT scan
- Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
- Video-assisted thoracoscopic lobectomy or bi-lobectomy
Key exclusion criteria (12 listed)
- Pneumonectomy, segmentectomy, non anatomic resection
- History of thoracic surgery on the same side
- Necessity to perform a non-anatomic resection in addition to the lobectomy
- No preoperative histological diagnosis
- Pure ground glass nodule on CT scan
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 |
|---|---|---|
| Vein interruption before any other surgical manipulationThe pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy). In the "vein first" group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner. | Procedure or surgery | Vein first |
| Arteries interruption before vein interruptionThe pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy). In the "arteries before vein" group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above. | Procedure or surgery | Arteries before vein |
Primary outcome
Changes in CTC density
Time frame: Within 96 hours after surgery
Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
Changes in CTC clusters density
Time frame: Within 96 hours after surgery
Changes in CTC clusters (or CTC micro-emboli defined as ≥3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample).
2 secondary outcomes
Disease free survival
Time frame: 2 years and 5 years after surgery
Overall survival
Time frame: 2 years and 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Results publication: PubMed 27468936Crosbie PA, Shah R, Krysiak P, Zhou C, Morris K, Tugwood J, Booton R, Blackhall F, Dive C. Circulating Tumor Cells Detected in the Tumor-Draining Pulmonary Vein Are Associated with Disease Recurrence after Surgical Resection of NSCLC. J Thorac Oncol. 2016 Oct;11(10):1793-7. doi: 10.1016/j.jtho.2016.06.017. Epub 2016 Jul 25.
- Results publication: PubMed 24618055Hashimoto M, Tanaka F, Yoneda K, Takuwa T, Matsumoto S, Okumura Y, Kondo N, Tsubota N, Tsujimura T, Tabata C, Nakano T, Hasegawa S. Significant increase in circulating tumour cells in pulmonary venous blood during surgical manipulation in patients with primary lung cancer. Interact Cardiovasc Thorac Surg. 2014 Jun;18(6):775-83. doi: 10.1093/icvts/ivu048. Epub 2014 Mar 11.
- 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.
Massimo Conti, MD principal investigator
Centre de Recherche IUCPQ - Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein interruption before any other surgical manipulation and Arteries interruption before vein interruption in people with Circulating Tumor Cell and Lung Cancer, run by Laval University at 1 site in Canada.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conti Massimo, MD (+14186568711 ext. 3853, massimo.conti@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in CTC density (time frame: Within 96 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645252, which also lists 2 linked publications.
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 24 Aug 2018.