Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study) (TEN)

January 12, 2024 updated by: Anne Sibille, Centre Hospitalier Universitaire de Liege

The primary objective is to describe eosinophil infiltration in resected (early stage) NSCLC.

Secondary objectives are:

  • to investigate the correlation of T-Eos and B-Eos in the aforementioned patient population;
  • to investigate the correlation between T-Eos and overall & disease-free survival;
  • to investigate the localization of T-Eos (periphery vs. center of the tumor lesions).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liège

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue for analysis will be included.

Description

Inclusion Criteria:

  • Resected, early stage NSCLC between 01-01-2015 and 30-04-2022 with available tumour tissue

Exclusion Criteria:

  • Inclusion in a clinical study contraindicating enrollment in the present study

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
Time Frame
Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification
Time Frame: October 2022
October 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population
Time Frame: December 2022
Tissue and blood eosinophil correlation
December 2022
to investigate the correlation between T-Eos and overall & disease-free survival
Time Frame: December 2022
overall and disease-free survival
December 2022
to investigate the localization of T-Eos (periphery vs. center of the tumor lesions)
Time Frame: December 2022
tissue eosinophil localisation
December 2022

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Liege

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 (Actual)

October 3, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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