NCT05032768 The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
| NCT ID | NCT05032768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Radiation Dermatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2021-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-01-01 with a primary completion date of 2021-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Female patients 2. Invasive breast cancer confirmed by pathology 3. Underwent mastectomy and breast reconstruction 4. Radiotherapy after breast reconstruction 5. ECOG score 0-1 6. Signed informed consent Exclusion Criteria: 1. Previous breast or chest radiotherapy 2. Other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy 3. Pregnant women 4. Patients who are unwilling or unable to receive regular follow-up.
Contact & Investigator
Xiaoli Yu, MD, Ph.D
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05032768 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Radiation Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05032768 currently recruiting?
Yes, NCT05032768 is actively recruiting participants. Contact the research team at wei.shi118@foxmail.com for enrollment information.
Where is the NCT05032768 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05032768 clinical trial?
NCT05032768 is sponsored by Fudan University. The principal investigator is Xiaoli Yu, MD, Ph.D at Fudan University. The trial plans to enroll 100 participants.