Tissue Eosinophils in Non-Small Cell Lung Cancer (the TEN... | NCT05537701

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

NCT05537701

Sponsor

Centre Hospitalier Universitaire de Liege

Status

Active, not recruiting

Last Update Posted

Jan 16, 2024Actual

Enrollment

316Actual

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2022Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2024

Last Update Posted Date

Jan 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anne Sibille, Principal investigator, Centre Hospitalier Universitaire de LiegePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire de LiegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

316Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
to investigate the correlation of tissue (T)-Eos and blood (B)-Eos in the aforementioned patient population	Tissue and blood eosinophil correlation	December 2022
to investigate the correlation between T-Eos and overall & disease-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Liege		Liège		4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided