Research for Predictive Biologic Parameters of Cutaneous... | NCT00922961

Studies
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer

NCT00922961

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Jul 23, 2012Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Blood sample
Clinical exam

Countries

France

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

Jul 2012

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

Sep 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 2009Estimated

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

Jul 20, 2012

Last Update Posted Date

Jul 23, 2012Estimated

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

25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.

During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)

Detailed Description

This is an interventional study for the french law

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cellular apoptosis	Experimental		Biological: Blood sample Procedure: Clinical exam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Biological	Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis	cellular apoptosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis		Blood sample during a consultation

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite		During a consultation with 2 physicians
Assessment of the rate of telangiectasia		During a consultation with 2 physicians

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
Patient with social security

Exclusion Criteria:

Not applicable

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yazid BELKACEMI, MD	Centre Oscar Lambret	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Oscar Lambret		Lille		59020	France

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided