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Trial record 8 of 5016 for:    NSCLC

Evaluation of PD1 / PDL1 Expression on Blood Cells & Tumor Tissue, Their Role as a Prognostic Target in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02758314
Recruitment Status : Unknown
Verified November 2016 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

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.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Other: Evaluation of PD-1/PDL-1 expression.

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : March 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.

Other: 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

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)

Other: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Whole blood cells, serum and plasma, tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).

Criteria

Inclusion Criteria patient :

  1. Patients who have understood and signed the informed consent.
  2. 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.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and evidence of measurable disease.

Exclusion Criteria patient:

  1. Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma.
  2. Subjects with acute inflammation and uncontrolled infections.

Inclusion Criteria healthy subjects :

  1. Informed consent in writing (signed) to participate in the study.
  2. No diagnosis of oncological disease.
  3. 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758314


Contacts
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Contact: Oscar Gerardo MD Arrieta Rodriguez, Oncology 01 52 556280400 ext 71101 ogarrieta@gmail.com, ogartsrr@yahoo.com.mx
Contact: GRACIELA Cruz, Biochemistry 015556280400 ext 71101 gracielacr@hotmail.com

Locations
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Mexico
Instituto National de Cancerologia Recruiting
Mexico, Mexico, 14080
Contact: Oscar Gerardo MD Arrieta, Oncology    015556280400 ext 71101    ogarrieta@gmail.com   
Contact: Graciela Cruz, Biochemistry    015556280400 ext 31048    gracielacr@hotmail.com   
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Oscar Gerardo MD Arrieta Rodriguez, Oncology Instituto Nacional de Cancerologia, Mexico

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, Director and Head of Functional Unit of Thoracic Oncology and Personalized Medicine Laboratory. SNI III, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT02758314     History of Changes
Other Study ID Numbers: INCAN/CI/498/13
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
PD-1
PD-L1
NSCLC

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms