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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT patients | 100 patients with breast cancer undergoing radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of skin culture samples | Diagnostic Test | Collection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dermatitis grade | 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. | through study completion, an average of 1 year |
| Microbiome composition | Collection of skin culture samples from body regions surrounding the RT treatment area and a control area | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Validation Procedure of evaluation of Radiation Dermatitis grade by the our application (Radia-App) | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer undergoing radiation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Roxolyana Abdah-Borthnyak, MD | Director, Radiation Service for Female Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | Israel |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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Skin microbiome samples
|
| D014947 |
| Wounds and Injuries |