Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer (MAMMOSITE2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00922961
First received: June 15, 2009
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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)


Condition Intervention
Breast Cancer
Biological: Blood sample
Procedure: Clinical exam

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis [ Time Frame: Blood sample during a consultation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the rate and scores of late fibrosis related to irradiation by mammosite [ Time Frame: During a consultation with 2 physicians ] [ Designated as safety issue: No ]
  • Assessment of the rate of telangiectasia [ Time Frame: During a consultation with 2 physicians ] [ Designated as safety issue: No ]
  • Assessment of the rate of sequellar pain [ Time Frame: During a consultation with 2 physicians ] [ Designated as safety issue: No ]
  • Assessment of the rate of seroma collection [ Time Frame: During a consultation with 2 physicians ] [ Designated as safety issue: No ]
  • Assessment of the breast esthetic score [ Time Frame: During a consultation with 2 physicians ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cellular apoptosis Biological: Blood sample
Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
Other Name: Blood sample
Procedure: Clinical exam
Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians
Other Name: Clinical exam

Detailed Description:

This is an interventional study for the french law

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922961

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Yazid BELKACEMI, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00922961     History of Changes
Other Study ID Numbers: MAMMOSITE2
Study First Received: June 15, 2009
Last Updated: July 20, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Oscar Lambret:
brachytherapy, late cutaneous toxicity

Additional relevant MeSH terms:
Hypersensitivity
Breast Neoplasms
Dermatitis, Atopic
Immune System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
Skin Diseases, Eczematous
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 19, 2014