The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients

NCT05032768 | Recruiting

• 1 other identifier: FDRT-BC015
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis; Skin Microbiome; Breast Cancer; Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• Skin microbiome differences between patients with and without >=2 acute radiation dermatitis

  Acute radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)

  3 months

Secondary Outcomes (1)

• Skin microbiome differences between patients with and without >=2 late radiation dermatitis

  5 years

Study Arms (2)

Severe radiation dermatitis

RTOG/EORTC grade 2 and above

Radiation: post-operative radiotherapy

No or mild radiation dermatitis

RTOG/EORTC grade 0 or 1

Radiation: post-operative radiotherapy

Interventions

post-operative radiotherapy RADIATION

Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.

No or mild radiation dermatitis; Severe radiation dermatitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who have underwent mastectomy and breast reconstruction and who will receive post-operative radiotherapy.

You may qualify if:

• Female patients
• Invasive breast cancer confirmed by pathology
• Underwent mastectomy and breast reconstruction
• Radiotherapy after breast reconstruction
• ECOG score 0-1
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The skin microbiome will be collected and analyzed. Bacteria 16S rRNA amplicon sequencing and fungal rRNA its (internal transcribed spacer) sequencing will be used to analyze skin microorganisms (including bacteria and fungi)

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Xiaoli Yu, MD, Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Shi, MD, Ph.D

CONTACT

+86 18121299680; wei.shi118@foxmail.com

Li Zhang, MD

CONTACT

zhangliaaa111@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

CN (1)