- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02758314
Evaluation of PD1 / PDL1 Expression on Blood Cells & Tumor Tissue, Their Role as a Prognostic Target in NSCLC Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Oscar Gerardo MD Arrieta Rodriguez, Oncology
- Phone Number: 71101 01 52 556280400
- Email: ogarrieta@gmail.com, ogartsrr@yahoo.com.mx
Study Contact Backup
- Name: GRACIELA Cruz, Biochemistry
- Phone Number: 71101 015556280400
- Email: gracielacr@hotmail.com
Study Locations
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Mexico, Mexico, 14080
- Instituto National de Cancerologia
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Contact:
- Oscar Gerardo MD Arrieta, Oncology
- Phone Number: 71101 015556280400
- Email: ogarrieta@gmail.com
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Contact:
- Graciela Cruz, Biochemistry
- Phone Number: 31048 015556280400
- Email: gracielacr@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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).
Description
Inclusion Criteria patient :
- 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.
Exclusion Criteria patient:
- Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
- Subjects with acute inflammation and uncontrolled infections.
Inclusion Criteria healthy subjects :
- 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.
Exclusion criteria healthy volunteers.
1. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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
|
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) |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC)
Time Frame: Baseline evaluation
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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.
|
Baseline evaluation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of PD-1, PD-L1 by flow cytometry.
Time Frame: Baseline evaluation
|
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.
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Baseline evaluation
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Collaborators and Investigators
Investigators
- Principal Investigator: Oscar Gerardo MD Arrieta Rodriguez, Oncology, Instituto Nacional de Cancerologia, Mexico
Publications and helpful links
General 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.
- Greenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.
- Pennock 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.
- Su 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.
- Arrieta 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCAN/CI/498/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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