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
1 other identifier
observational
150
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 25, 2016
November 1, 2016
9 months
April 6, 2016
November 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline evaluation
Secondary Outcomes (1)
Evaluation of PD-1, PD-L1 by flow cytometry.
Baseline evaluation
Study Arms (2)
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.
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)
Interventions
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
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
- Subjects with acute inflammation and uncontrolled infections.
- 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.
- \. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto National de Cancerologia
México, State of Mexico, 14080, Mexico
Related Publications (5)
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.
PMID: 24048123BACKGROUNDGreenwald RJ, Freeman GJ, Sharpe AH. The B7 family revisited. Annu Rev Immunol. 2005;23:515-48. doi: 10.1146/annurev.immunol.23.021704.115611.
PMID: 15771580BACKGROUNDPennock 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.
PMID: 26069281BACKGROUNDSu 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.
PMID: 27039716BACKGROUNDArrieta 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.
PMID: 29254220DERIVED
Biospecimen
Whole blood cells, serum and plasma, tumor tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oscar Gerardo MD Arrieta Rodriguez, Oncology
Instituto Nacional de Cancerologia, Mexico
Central Study Contacts
Oscar Gerardo MD Arrieta Rodriguez, Oncology
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director and Head of Functional Unit of Thoracic Oncology and Personalized Medicine Laboratory. SNI III
Study Record Dates
First Submitted
April 6, 2016
First Posted
May 2, 2016
Study Start
March 1, 2017
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
November 25, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share