The Association Between Radiation Dermatitis and Skin Mic... | NCT05032768

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

NCT05032768

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Sep 2, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Radiation Dermatitis
Skin Microbiome
Breast Cancer
Reconstructive Surgery

Interventions

post-operative radiotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jul 25, 2021

First Submission Date that Met QC Criteria

Sep 1, 2021

First Posted Date

Sep 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Radiotherapy is an important treatment for breast cancer patients. About 95% of patients receiving radiotherapy will develop a degree of radiation dermatitis. Radiation dermatitis is usually limited to the site of radiation treatment. Symptoms vary and can range from itching, burning and pain to open or bleeding ulcers, which can greatly affect the quality of life of patients. Severe acute radiation dermatitis can lead to interruption or delay of treatment. At present, there is no standard for the prevention and treatment of radiation dermatitis. Our skin is home to millions of bacteria, fungi and viruses which compose the skin microbiota. Skin microbiota interacts with skin and affects physiology and immunity of the skin. Previous studies have reported the effects of radiotherapy on skin and immune system. However, so far, no studies have analyzed the effects of radiotherapy on skin microbiome and how skin microbiome affects the skin immune responses after radiotherapy. In this study, 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. The long-term goal of this study is to deepen the understanding of the role of skin microbiome in the occurrence and development of radiation dermatitis, and provide a basis for subsequent exploration to reduce radiation dermatitis by regulating skin microecology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
post-operative radiotherapy	Radiation	Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.	No or mild radiation dermatitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Skin microbiome differences between patients with and without >=2 late radiation dermatitis	Late radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wei Shi, MD, Ph.D	Contact	+86 18121299680		wei.shi118@foxmail.com
Li Zhang, MD	Contact			zhangliaaa111@163.com

Overall Officials

Name	Affiliation	Role
Xiaoli Yu, MD, Ph.D	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011855	Radiodermatitis
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D011832	Radiation Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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)