The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
Recruiting · NCT05032768 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
post-operative radiotherapy
What this trial is about
The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Female patients
- Invasive breast cancer confirmed by pathology
- Underwent mastectomy and breast reconstruction
- Radiotherapy after breast reconstruction
- ECOG score 0-1
- Signed informed consent
Exclusion criteria
- Previous breast or chest radiotherapy
- Other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy
- Pregnant women
- Patients who are unwilling or unable to receive regular follow-up.
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China