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Completed

NCT Number: NCT00922961

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

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)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

This is an interventional study for the french law

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

Clinical exam

Procedure

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

Primary outcomes

  1. Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis

    Time frame: Blood sample during a consultation

Secondary outcomes

  1. Assessment of the rate and scores of late fibrosis related to irradiation by mammosite

    Time frame: During a consultation with 2 physicians

  2. Assessment of the rate of telangiectasia

    Time frame: During a consultation with 2 physicians

  3. Assessment of the rate of sequellar pain

    Time frame: During a consultation with 2 physicians

  4. Assessment of the rate of seroma collection

    Time frame: During a consultation with 2 physicians

  5. Assessment of the breast esthetic score

    Time frame: During a consultation with 2 physicians

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Acronym: MAMMOSITE2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 17, 2009
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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