Characterization of Skin Microbiome Profile Before and During Radiation Therapy and it's Correlation to the Occurrence and Severity of Radiation Dermatitis
试验速览
- 阶段
- 不适用
- 发起方
- AceTech
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radiation Dermatitis grade
研究概览
简要总结
The purpose of this study is to characterize the skin microbiome profile of breast cancer patients before and after receiving Radio Therapy treatments, and evaluate the relationship between the microbiome profile and radiation dermatitis severity (grade) that the patient will develop. Such characterizations can lead to potential biomarkers and/or therapeutic targets that can be used for the prognosis, prevention and treatment of this condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histological confirmation of breast malignancy
- •Primary or recurrent disease eligible
- •Patients after breast lumpectomy and that scheduled to receive radiotherapy
- •Patients that receive minimum of 45 Gy
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
排除标准
- •Patients with prior radiotherapy to any portion of the planned treatment site
- •Tumour involvement of the skin
- •Patients with active rash, pre-existing dermatitis, lupus, or scleroderma
- •Patient with other skin diseases/ skin disorders
- •Recent use of systemic or topical antibiotics or antifungal medications within 21 days of first swab collection.
- •Recent use of any of the following within 21 days of first swab collection: o Systemic or topical steroids o Use of systemic immunosuppressant drugs o Use of ultraviolet light therapy
- •Prior usage of other topical and systemic medications within 21 days of first swab collection
- •Prior usage of topical cosmetic products, creams, lotions, or gels within 14 days of first swab collection in areas where samples are taken.
- •Clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome
- •Prior organ or bone marrow transplant
- •Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
结局指标
主要结局
Radiation Dermatitis grade
时间窗: through study completion, an average of 1 year
Study participant will be evaluated by physician and nurse for the occurrence and the severity of RD. Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring.
Microbiome composition
时间窗: through study completion, an average of 1 year
Collection of skin culture samples from body regions surrounding the RT treatment area and a control area
次要结局
- Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App)(through study completion, an average of 1 year)