Retrospective Study Evaluating IGF1R And p95HER2 as Progn... | NCT00763607

Studies
Retrospective Study Evaluating IGF1R And p95HER2 as Prognostic Factors in Non Small Cell Lung Cancer (NSCLC)

NCT00763607

Sponsor

Armando Santoro, MD

Status

Completed

Last Update Posted

Sep 10, 2022Actual

Enrollment

454Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Protein expression by immunohistochemistry and immunofluorescence

Countries

Italy

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 30, 2008

First Submission Date that Met QC Criteria

Sep 30, 2008

First Posted Date

Oct 1, 2008Estimated

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

Sep 8, 2022

Last Update Posted Date

Sep 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Aim of the study is to evaluated the role of IGF1R and p95HER2 on prognosis in radically resected non small cell lung cancer patients

The primary objective is to correlate the expression of IGF1R and p95HER2 with survival.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

454Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Radically resected Non small cell lung cancer patients in stage I-III	Genetic: Protein expression by immunohistochemistry and immunofluorescence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protein expression by immunohistochemistry and immunofluorescence	Genetic	Protein expression by immunohistochemistry and immunofluorescence	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of different biomarkers with survival		At the end of enrollment

Secondary Outcomes

Measure	Description	Time Frame
Association of a specific biomarker with patient's characteristics		At the end of enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Radically resected non small cell lung cancer patients with tumor tissue available

Exclusion Criteria:

Tumor tissue not available
Clinical data not available

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

Radically resected non small cell lung cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Santoro, MD	Istituto Clinico Humanitas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinco Humanitas		Rozzano	Milan	20089	Italy

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

Intervention Browse Module

MeSH Terms

ID	Term
D005455	Fluorescent Antibody Technique

Ancestor Terms

ID	Term
D007150	Immunohistochemistry
D006651	Histocytochemistry
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided