MicrobiotaNCT04132713
Study on Skin Microbiome of HFS
An observational study of Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Capecitabine 150Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to 15 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients were included according to the inclusion and exclusion criteria
Who may be able to join
- age: 18-65 years old
- advanced breast cancer patients
- healthy volunteers
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yunwei Wei, +86-0451-85553099, hydwyw11@hotmail.com
About this study
Official title: Study on Skin Microbiota of Hand Foot Syndrome
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.
Read the detailed description
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
- Conditions
- Microbiota
- Being tested
- Capecitabine 150Mg Oral Tablet
- Keywords
- skin microbiota, 16S rRNA gene, hand foot sysdom, breast cancer chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine 150Mg Oral TabletDrug
Advanced breast cancer patients with first-line medication
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Capecitabine 150Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional changes in skin microbiota
The microbiota measured by 16S rRNA gene
Measured: baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start10 Sep 2019
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132713
- Sponsor's protocol ID
- Yunwei Wei 2019-09-12
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23331690Kong 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.
PubMed 22189793Roth RR, James WD. Microbiology of the skin: resident flora, ecology, infection. J Am Acad Dermatol. 1989 Mar;20(3):367-90. doi: 10.1016/s0190-9622(89)70048-7.
PubMed 2645319
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Skin Microbiota of Hand Foot Syndrome
- ClinicalTrials.gov ID
- NCT04132713
- Acronym / sponsor ID
- Yunwei Wei 2019-09-12
- Conditions
- Microbiota
- Keywords
- skin microbiota, 16S rRNA gene, hand foot sysdom, breast cancer chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –20 healthy volunteers were included in the healthy control group |
| Disease group | – | Drug: Capecitabine 150Mg Oral Tablet30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were included according to the inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- age: 18-65 years old
- advanced breast cancer patients
- healthy volunteers
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine 150Mg Oral TabletAdvanced breast cancer patients with first-line medication | Drug | Disease group |
Primary outcome
Transcriptional changes in skin microbiota
Time frame: baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days
The microbiota measured by 16S rRNA gene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Background: PubMed 23331690Weese 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.
- Background: PubMed 22189793Kong 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.
- Background: PubMed 2645319Roth RR, James WD. Microbiology of the skin: resident flora, ecology, infection. J Am Acad Dermatol. 1989 Mar;20(3):367-90. doi: 10.1016/s0190-9622(89)70048-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunwei Wei, doctor (+86-0451-85553099, hydwyw11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional changes in skin microbiota (time frame: baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04132713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.