Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
Sponsor
Centre Hospitalier Universitaire de Liege (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05537701
Collaborator
(none)
400
3
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN Study)
Anticipated Study Start Date
:
Sep 1, 2022
Anticipated Primary Completion Date
:
Nov 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Outcome Measures
Primary Outcome Measures
- Percentage of tumor associated tissue eosinophilia by immunohistochemistry and computerised quantification [October 2022]
Secondary Outcome Measures
- to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population [December 2022]
Tissue and blood eosinophil correlation
- to investigate the correlation between T-Eos and overall & disease-free survival [December 2022]
overall and disease-free survival
- to investigate the localization of T-Eos (periphery vs. center of the tumor lesions) [December 2022]
tissue eosinophil localisation
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier Universitaire de Liege
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Anne Sibille,
Principal investigator,
Centre Hospitalier Universitaire de Liege
ClinicalTrials.gov Identifier:
NCT05537701
Other Study ID Numbers:
- 2022/158
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: