The Impact of Polynuclear Neutrophils' Intra-tumoral Rate and the Mutational Status in Pulmonary Adenocarcinomas on Survival

February 16, 2021 updated by: Guillaume GAUCHOTTE, Central Hospital, Nancy, France

Study Concerning the Impact of Polynuclear Neutrophils' Intra-tumoral Rate and the Mutational Status in Pulmonary Adenocarcinomas on Chance of Survival.

Lung cancer is one of the most frequent cancer concerning human beings and it represents, worldwide, one of the first cause of death. Most of patients with this cancer are males and 85% of lung cancers are non-small cells type (NSCLC) with adenocarcinoma being the most common histologic subtype.

Patients with pulmonary cancer have a poor long-term prognosis with an overall 5 years of survival which is less than 25% for all stages.

The natural immune system, with polynuclear neutrophils (PNN) is involved in carcinogenesis. The impact of PNN localized within the tumor as a prognostic biomarker has not been really studied in non-small cells lung cancers.

According to some studies, an increase in the number of PNN (labelled by the CD66b antibody) within the tumor is associated to a greater risk of relapse and a poor overall survival rate.

The intra-tumoral ratio PNN over Lymphocytes T CD8 + (iNTR) is an independent factor of the poor prognosis concerning the overall survival rate and concerning risk of relapse with patients who went through a first surgery for a non-small cells lung cancer.

With this study we will initially concentrate on lung adenocarcinoma and attempt to evaluate the PNN's rate within the tumor and its impact on an overall survival rate and progression-free survival.

Secondly, we will explore the role of iNTR and the mutational profile of tumors concerning this survival.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stages I to III lung adenocarcinoma (TNM UICC 8ème édition) who went through a first surgery with a lymph node dissection at the CHRU of Nancy.

Description

Inclusion Criteria:

  • Patients with stages I to III lung adenocarcinoma (TNM UICC 8ème édition)
  • Patients who went through a first surgery with a lymph node dissection at the CHRU of Nancy between 01/01/2010 and 01/01/2012
  • Patients included in the CRB CHRU-INSERM bronchial collection

Exclusion Criteria:

  • patients who received neoadjuvant therapy.
  • Stage IV patients (TNM UICC 8ème édition)
  • Patients whose surgical resection was incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study concerning the association between the rates of intra tumoral PNN and overall survival rate (and without recurrence).
Time Frame: baseline

The total number of PNN will be determined by cellular counting on HES slides. The total number of PNN CD66 +, and MPO + will be determined by cell count after immunohistochemical analysis.

The appearance of lymph node metastasis or distant metastasis will be considered as a recurrence.

The date of the initial surgery, the vital status (deceased/ alive), the possible date of the recurrence as well as the date of death and/ or latest news will be used to estimate the survival rate (with or without recurrence)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI278

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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