Lung CancerPOIRNCT03549546
Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
A study testing Blood samples in people with Lung Cancer and Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2018to 12 Feb 2019
- 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
- Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy
Who cannot join
- Patient under guardianship/curatorship
- Patient who received of radiotherapy or chemotherapy in the last 6 months
- Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
- Patient with history of malignant blood disease or auto-immune disease
- Patient suffering from HIV infection and
- Patients with pre-operative infection
- Patient with an empiric antibiotic therapy introduced at operating room
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.
Read the detailed description
This study will investigate prospectively TIM-3, PD-1 and CTLA4 expression on lymphocytes T cells before and after lung cancer surgery. Patients ≥ 18 years with no history of immunosuppressive state will be included.
- Conditions
- Lung Cancer, Surgery
- Being tested
- Blood samples
- Keywords
- Lymphopenia, Lung cancer surgery, TIM-3, PD-1, CTLA-4, lymphocytes, CD4, CD8
- Medical subject headings
- Lung Neoplasms, Lymphopenia, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Blood samples will be collected in patients undergoing lung cancer surgery:
- before lung cancer surgery,
- the next day lung cancer surgery,
- 3 days after lung cancer surgery. They will be treated in flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing lung cancer surgery | Other | Patients undergoing lung cancer surgery will be included. Blood samples will be collected. Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes
Correlation between expression of PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes and the occurrence of lymphopenia.
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
Measured: Days 0, 1, 3
Secondary outcomes (2)
functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2
Correlation between functionality of CD4/CD8 lymphocytes and production of interferon (IF) gamma, Tumor Necrosis Factor (TNF) and interleukine (IL-2).
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
Measured: Days 0, 1, 3
pneumonia
To analyse the occurrence of postoperative pneumonia.
Measured: Days 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start14 Jun 2018
- Primary completion6 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Dupont, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549546
- Sponsor's protocol ID
- 1708182
- Other IDs
- 2017-A03391-52
- Acronym
- POIR
- Status last verified
- Dec 2018
- First submitted
- 25 May 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- 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 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
- ClinicalTrials.gov ID
- NCT03549546
- Acronym / sponsor ID
- POIR / 1708182
- Conditions
- Lung Cancer, Surgery
- Keywords
- Lymphopenia, Lung cancer surgery, TIM-3, PD-1, CTLA-4, lymphocytes, CD4, CD8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 8 Jun 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.
Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.
Detailed description
This study will investigate prospectively TIM-3, PD-1 and CTLA4 expression on lymphocytes T cells before and after lung cancer surgery. Patients ≥ 18 years with no history of immunosuppressive state will be included.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing lung cancer surgery | Other | Biological: Blood samplesPatients undergoing lung cancer surgery will be included. Blood samples 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 ≥ 18 years undergoing lung cancer surgery by thoracoscopy
Key exclusion criteria (7 listed)
- Patient under guardianship/curatorship
- Patient who received of radiotherapy or chemotherapy in the last 6 months
- Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
- Patient with history of malignant blood disease or auto-immune disease
- Patient suffering from HIV infection and
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 samplesBlood samples will be collected in patients undergoing lung cancer surgery: * before lung cancer surgery, * the next day lung cancer surgery, * 3 days after lung cancer surgery. They will be treated in flow cytometry. | Biological | Patients undergoing lung cancer surgery |
Primary outcome
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes
Time frame: Days 0, 1, 3
Correlation between expression of PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes and the occurrence of lymphopenia. Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
2 secondary outcomes
functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2
Time frame: Days 0, 1, 3
pneumonia
Time frame: Days 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Guillaume Dupont, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 samples in people with Lung Cancer and Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 26 Jul 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes (time frame: Days 0, 1, 3). 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 26 Jul 2019.