Study on Skin Microbiome of HFS | NCT04132713

Studies
Study on Skin Microbiome of HFS

NCT04132713

Sponsor

First Affiliated Hospital of Harbin Medical University

Status

Unknown status

Last Update Posted

Oct 21, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Microbiota

Interventions

Capecitabine 150Mg Oral Tablet

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 10, 2019Actual

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Oct 15, 2020Estimated

First Submitted Date

Oct 17, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

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

Oct 18, 2019

Last Update Posted Date

Oct 21, 2019Actual

Name	Class
Sponsor GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.

Detailed Description

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

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group		20 healthy volunteers were included in the healthy control group
Disease group		30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration	Drug: Capecitabine 150Mg Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capecitabine 150Mg Oral Tablet	Drug	Advanced breast cancer patients with first-line medication	Disease group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcriptional changes in skin microbiota	The microbiota measured by 16S rRNA gene	baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 18-65 years old
advanced breast cancer patients
healthy volunteers

Exclusion Criteria:

previous skin disease history, or other skin disease activity at present
various antibiotics, prebiotics, probiotics or lactic acid products used within three months;
having a history of alcoholism for more than 2 years and smoking for years;
pregnancy or lactation;
have oral, respiratory and gastrointestinal diseases;
other metabolic diseases, such as obesity, hypertension, diabetes, stones, and liver diseases;
other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease;
history of gastrointestinal surgery;
family genetic history, history of mental illness, etc.;
the subject is participating in other research projects;
other reasons are not considered suitable for continued clinical trials.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

All patients were included according to the inclusion and exclusion criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunwei Wei, doctor	Contact	+86-0451-85553099		hydwyw11@hotmail.com
xin Wu	Contact	+86-0451-85553099		wuxin199509@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First affiliated hospital of Harbin medical university	Recruiting	Harbin	Heilongjiang	150001	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23331690	Background	Weese JS. The canine and feline skin microbiome in health and disease. Vet Dermatol. 2013 Feb;24(1):137-45.e31. doi: 10.1111/j.1365-3164.2012.01076.x.
22189793	Background	Kong HH, Segre JA. Skin microbiome: looking back to move forward. J Invest Dermatol. 2012 Mar;132(3 Pt 2):933-9. doi: 10.1038/jid.2011.417. Epub 2011 Dec 22.

ID	Term
D000069287	Capecitabine
D013607	Tablets

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines