NCT00922961

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

June 15, 2009

Last Update Submit

July 20, 2012

Conditions

Breast Cancer

Keywords

brachytherapy, late cutaneous toxicity

Outcome Measures

Primary Outcomes (1)

  • Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis

    Blood sample during a consultation

Secondary Outcomes (5)

  • 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

  • Assessment of the rate of sequellar pain

    During a consultation with 2 physicians

  • Assessment of the rate of seroma collection

    During a consultation with 2 physicians

  • Assessment of the breast esthetic score

    During a consultation with 2 physicians

Study Arms (1)

cellular apoptosis

EXPERIMENTAL
Biological: Blood sampleProcedure: Clinical exam

Interventions

Blood sampleBIOLOGICAL

Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis

cellular apoptosis
Clinical examPROCEDURE

Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians

cellular apoptosis

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Yazid BELKACEMI, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

September 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

FR(1)