Non-Small Cell Lung CancerNCT02758314
Evaluation of PD1 / PDL1 Expression on Blood Cells & Tumor Tissue, Their Role as a Prognostic Target in NSCLC Patients
An observational study of Non-Small Cell Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1 (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer patients, particularly in those with lung… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Evaluation of PD-1/PDL-1 expression.
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2017to Dec 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: It will include patients diagnosed with advanced non-small cell lung adenocarcinoma (clinical stages IIIA, IIIB and IV) treated at the Instituto Nacional de Cancerología (INCan). Subjects without previous radiotherapy and / or chemotherapy (prior sampling).
Who may be able to join
- Patients who have understood and signed the informed consent.
- Diagnosis of lung cancer, histologically or cytologically documented (stage IIIA / B or IV) non-small cell adenocarcinoma, which had not received radiotherapy and / or chemotherapy prior to the first sample.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and evidence of measurable disease.
- Informed consent in writing (signed) to participate in the study.
- No diagnosis of oncological disease.
- Subjects without symptoms of any respiratory illness in the two weeks prior to sampling.
Who cannot join
- Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
- Subjects with acute inflammation and uncontrolled infections.
- 1. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).
Trial locations and contacts
1 site in 1 country.
Oscar Gerardo MD Arrieta Rodriguez, Oncology contact
Mexico1 site
Instituto National de Cancerologia
México, State of Mexico, 14080
Oscar Gerardo MD Arrieta, Oncology, 015556280400 ext. 71101, ogarrieta@gmail.com
Graciela Cruz, Biochemistry, 015556280400 ext. 31048, gracielacr@hotmail.com
About this study
Official title: Clinical Pathological Features Associated With the Expression of PD1 / PD-L1 in Subpopulations of Peripheral Blood and Tumor Tissue in Patients With Advanced Non-small Cell Lung Cancer, Their Role as Prognostic and Therapeutic Targets
Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1 (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer patients, particularly in those with lung cancer, has not been sufficiently studied. The purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC), associating with clinicopathological features of the patients studied.
Read the detailed description
This is a prospective cohort study including patients with NSCLC stages IIIA, IIIB and IV lung cancer clinic of the National Cancer Institute (INCAN)
Clinical samples. Prior and informed consent before receiving any treatment, sample be obtained 15 ml peripheral blood of each subject included in the study (patients and controls). mononuclear peripheral blood cells (PBMC) from different groups of subjects separated by centrifugation gradient (Polymorphprep, Accurate Chemical) are used. The cells are resuspended in dimethylsulfoxide (DMSO) and 10% fetal bovine serum (FBS) to 90% at a concentration of 1 million cells per ml and kept in liquid nitrogen until use.
Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti- cluster of differentiation (CD) 3, anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20.
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in <5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Evaluation of PD-1/PDL-1 expression.
- Keywords
- PD-1, PD-L1, NSCLC
- 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.
Evaluation of PD-1/PDL-1 expression.Other
Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations of peripheral blood by flow cytometry and in tumor tissue by immunohistochemistry in NSCLC, free treatment and healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| Cases / NSCLC patients | Evaluation of PD-1/PDL-1 expression.
Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations (CD3 + (CD4 +, CD8 +), B cells (CD19 + CD20 +), natural killer (NK) cells (CD16 + CD56 +) NK T-cells (CD3 + CD16 + CD56 + ) peripheral blood samples in 150 NSCLC, free treatment by flow cytometry.
Evaluate the expression of PD-1 / PD-L1 in tumor tissue obtained by biopsy of patients with NSCLC by immunohistochemistry.
The patients for the enrollment have to be diagnosed with advanced Non-Small Cell Lung Adenocarcinoma (clinical stages IIIA, IIIB and IV), treated at the Instituto Nacional de Cancerología (INCan) who had not received radiotherapy and / or chemotherapy prior to obtaining samples to analyze. ECOG performance status 0-2 and present evidence of measurable disease. Receives: Other: Evaluation of PD-1/PDL-1 expression. | |
| Control / Healthy subjects | Evaluation of PD-1/PDL-1 expression.
Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations (CD3 + (CD4 +, CD8 +), B cells (CD19 + CD20 +), natural killer (NK) cells (CD16 + CD56 +) NK T-cells (CD3 + CD16 + CD56 + ) peripheral blood samples in 50 samples, by flow cytometry.
Healthy subjects blood cells will be obtained from the blood bank at the Instituto Nacional de Cancerología (INCan) Receives: Other: Evaluation of PD-1/PDL-1 expression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC)
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in <5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.
Measured: Baseline evaluation
Secondary outcomes (1)
Evaluation of PD-1, PD-L1 by flow cytometry.
Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 3 (CD3), anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20.
Measured: Baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMar 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar Gerardo MD Arrieta Rodriguez, Oncology, Principal investigator, Instituto Nacional de Cancerologia, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758314
- Sponsor's protocol ID
- INCAN/CI/498/13
- Status last verified
- Nov 2016
- First submitted
- 6 Apr 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Gajewski TF, Schreiber H, Fu YX. Innate and adaptive immune cells in the tumor microenvironment. Nat Immunol. 2013 Oct;14(10):1014-22. doi: 10.1038/ni.2703.
PubMed 24048123Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.
PubMed 15771580Pennock GK, Chow LQ. The Evolving Role of Immune Checkpoint Inhibitors in Cancer Treatment. Oncologist. 2015 Jul;20(7):812-22. doi: 10.1634/theoncologist.2014-0422. Epub 2015 Jun 11.
PubMed 26069281Su M, Huang CX, Dai AP. Immune Checkpoint Inhibitors: Therapeutic Tools for Breast Cancer. Asian Pac J Cancer Prev. 2016;17(3):905-10. doi: 10.7314/apjcp.2016.17.3.905.
PubMed 27039716Arrieta O, Montes-Servin E, Hernandez-Martinez JM, Cardona AF, Casas-Ruiz E, Crispin JC, Motola D, Flores-Estrada D, Barrera L. Expression of PD-1/PD-L1 and PD-L2 in peripheral T-cells from non-small cell lung cancer patients. Oncotarget. 2017 Oct 24;8(60):101994-102005. doi: 10.18632/oncotarget.22025. eCollection 2017 Nov 24.
PubMed 29254220
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pathological Features Associated With the Expression of PD1 / PD-L1 in Subpopulations of Peripheral Blood and Tumor Tissue in Patients With Advanced Non-small Cell Lung Cancer, Their Role as Prognostic and Therapeutic Targets
- ClinicalTrials.gov ID
- NCT02758314
- Acronym / sponsor ID
- INCAN/CI/498/13
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- PD-1, PD-L1, NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- Mar 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 May 2016 (estimated)
- 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.
Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1 (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer patients, particularly in those with lung cancer, has not been sufficiently studied. The purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC), associating with clinicopathological features of the patients studied.
Detailed description
This is a prospective cohort study including patients with NSCLC stages IIIA, IIIB and IV lung cancer clinic of the National Cancer Institute (INCAN)
Clinical samples. Prior and informed consent before receiving any treatment, sample be obtained 15 ml peripheral blood of each subject included in the study (patients and controls). mononuclear peripheral blood cells (PBMC) from different groups of subjects separated by centrifugation gradient (Polymorphprep, Accurate Chemical) are used. The cells are resuspended in dimethylsulfoxide (DMSO) and 10% fetal bovine serum (FBS) to 90% at a concentration of 1 million cells per ml and kept in liquid nitrogen until use.
Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti- cluster of differentiation (CD) 3, anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20.
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in <5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases / NSCLC patients | – | Other: Evaluation of PD-1/PDL-1 expression.Evaluation of PD-1/PDL-1 expression. Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations (CD3 + (CD4 +, CD8 +), B cells (CD19 + CD20 +), natural killer (NK) cells (CD16 + CD56 +) NK T-cells (CD3 + CD16 + CD56 + ) peripheral blood samples in 150 NSCLC, free treatment by flow cytometry. Evaluate the expression of PD-1 / PD-L1 in tumor tissue obtained by biopsy of patients with NSCLC by immunohistochemistry. The patients for the enrollment have to be diagnosed with advanced Non-Small Cell Lung Adenocarcinoma (clinical stages IIIA, IIIB and IV), treated at the Instituto Nacional de Cancerología (INCan) who had not received radiotherapy and / or chemotherapy prior to obtaining samples to analyze. ECOG performance status 0-2 and present evidence of measurable disease. |
| Control / Healthy subjects | – | Other: Evaluation of PD-1/PDL-1 expression.Evaluation of PD-1/PDL-1 expression. Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations (CD3 + (CD4 +, CD8 +), B cells (CD19 + CD20 +), natural killer (NK) cells (CD16 + CD56 +) NK T-cells (CD3 + CD16 + CD56 + ) peripheral blood samples in 50 samples, by flow cytometry. Healthy subjects blood cells will be obtained from the blood bank at the Instituto Nacional de Cancerología (INCan) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It will include patients diagnosed with advanced non-small cell lung adenocarcinoma (clinical stages IIIA, IIIB and IV) treated at the Instituto Nacional de Cancerología (INCan). Subjects without previous radiotherapy and / or chemotherapy (prior sampling).
Key inclusion criteria (6 listed)
- Patients who have understood and signed the informed consent.
- Diagnosis of lung cancer, histologically or cytologically documented (stage IIIA / B or IV) non-small cell adenocarcinoma, which had not received radiotherapy and / or chemotherapy prior to the first sample.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and evidence of measurable disease.
- Informed consent in writing (signed) to participate in the study.
- No diagnosis of oncological disease.
Key exclusion criteria (3 listed)
- Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
- Subjects with acute inflammation and uncontrolled infections.
- 1. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).
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 |
|---|---|---|
| Evaluation of PD-1/PDL-1 expression.Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations of peripheral blood by flow cytometry and in tumor tissue by immunohistochemistry in NSCLC, free treatment and healthy subjects | Other | Cases / NSCLC patients, Control / Healthy subjects |
Primary outcome
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC)
Time frame: Baseline evaluation
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in <5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.
1 secondary outcome
Evaluation of PD-1, PD-L1 by flow cytometry.
Time frame: Baseline evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Background: PubMed 24048123Gajewski TF, Schreiber H, Fu YX. Innate and adaptive immune cells in the tumor microenvironment. Nat Immunol. 2013 Oct;14(10):1014-22. doi: 10.1038/ni.2703.
- Background: PubMed 15771580Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.
- Background: PubMed 26069281Pennock GK, Chow LQ. The Evolving Role of Immune Checkpoint Inhibitors in Cancer Treatment. Oncologist. 2015 Jul;20(7):812-22. doi: 10.1634/theoncologist.2014-0422. Epub 2015 Jun 11.
- Background: PubMed 27039716Su M, Huang CX, Dai AP. Immune Checkpoint Inhibitors: Therapeutic Tools for Breast Cancer. Asian Pac J Cancer Prev. 2016;17(3):905-10. doi: 10.7314/apjcp.2016.17.3.905.
- Derived from this study: PubMed 29254220Arrieta O, Montes-Servin E, Hernandez-Martinez JM, Cardona AF, Casas-Ruiz E, Crispin JC, Motola D, Flores-Estrada D, Barrera L. Expression of PD-1/PD-L1 and PD-L2 in peripheral T-cells from non-small cell lung cancer patients. Oncotarget. 2017 Oct 24;8(60):101994-102005. doi: 10.18632/oncotarget.22025. eCollection 2017 Nov 24.
- Individual participant dataSharing planned: Yes
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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.
Oscar Gerardo MD Arrieta Rodriguez, Oncology contact
Oscar Gerardo MD Arrieta Rodriguez, Oncology principal investigator
Instituto Nacional de Cancerologia, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Nov 2016. 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 Mexico. 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 Oscar Gerardo MD Arrieta Rodriguez, Oncology (01 52 556280400 ext. 71101, ogarrieta@gmail.com, ogartsrr@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC) (time frame: Baseline evaluation). 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 NCT02758314, which also lists 5 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 25 Nov 2016.