Retrospective Study Assessing Molecular Features Predicti... | NCT00491140

Studies
Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

NCT00491140

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Oct 1, 2008Estimated

Enrollment

85Actual

Phase

Not provided

Conditions

Colorectal Neoplasms

Interventions

Gene mutations analysis and FISH

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 2008

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

Dec 2006

Primary Completion Date

May 2007Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 22, 2007

First Submission Date that Met QC Criteria

Jun 22, 2007

First Posted Date

Jun 25, 2007Estimated

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 30, 2008

Last Update Posted Date

Oct 1, 2008Estimated

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

The primary objective is to identify molecular features predicting response or resistance to cetuximab

Detailed Description

Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

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

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation		Colorectal cancer patients	Genetic: Gene mutations analysis and FISH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gene mutations analysis and FISH	Genetic	FISH and mutation analysis of multiple genes	Observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of different biomarkers with Cetuximab sensitivity		Assessment every two months

Secondary Outcomes

Measure	Description	Time Frame
Association of different biomarkers with time to progression and survival		At the end of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion Criteria:

Less than 3 weeks after completion of previous radiotherapy

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

Colorectal cancer patients treated with Cetuximab

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Santoro, MD	Istituto Clinico Humanitas	Study Director

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15677699	Background	Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005 Mar 20;23(9):1803-10. doi: 10.1200/JCO.2005.08.037. Epub 2005 Jan 27.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D017403	In Situ Hybridization
D013194	Staining and Labeling
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques