MicrobiotaNCT03543891
Intestinal Microbiota and Thyroid Cancer
An observational study of Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Apr 2018
- 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
- All sexes
- 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
- Aged 18 to 65 years
- Patients of thyroid cancer
Who cannot join
- Pregnancy
- Lactation
- Cigarette smoking
- Alcohol addiction
- Hypertension
- Diabetes mellitus
Show all 11Show fewer
- Lipid dysregulation
- BMI > 27
- Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
- History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
- History of malignancy or any gastrointestinal tract surgery
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
About this study
Official title: Correlation Study of Thyroid Cancer and Intestinal Microbiota
Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.
Read the detailed description
Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. According to the China National Cancer Registry data in 2015 (3), there were estimated 90,000 new TC cases in China, and its incidence has risen sharply. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.
- Conditions
- Microbiota
- Keywords
- Gut microbiota, 16S rRNA gene, Thyroid cancer, Metabonomics
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Control group | 50 healthy volunteers were included in the healthy control group | |
| Thyroid cancer group | 50 patients of thyroid cancer were included |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional changes in gut microbiota
The microbiota measured by 16S rRNA gene
Measured: Baseline
Secondary outcomes (1)
Metabolic changes in gut microbiota
Metabolic changes measured by metabonomics analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Sep 2017
- Primary completion28 Feb 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunwei Wei, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543891
- Sponsor's protocol ID
- Yunwei Wei 2018-05-20
- Status last verified
- Sep 2017
- First submitted
- 21 May 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study of Thyroid Cancer and Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT03543891
- Acronym / sponsor ID
- Yunwei Wei 2018-05-20
- Conditions
- Microbiota
- Keywords
- Gut microbiota, 16S rRNA gene, Thyroid cancer, Metabonomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 1 Jun 2018 (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.
Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.
Detailed description
Thyroid cancer (TC), the most common malignancy of the endocrine system, is currently the fifth most common malignancy diagnosed in women (1). The incidence of TC in the United States has increased by an average of 3% per year over the past 4 decades. According to the China National Cancer Registry data in 2015 (3), there were estimated 90,000 new TC cases in China, and its incidence has risen sharply. Much progress has been made in exploring the etiology and pathogenesis of thyroid cancer, while the exact etiology remains unknown, TC is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. Besides the improvement of diagnosis, TC increasing incidence emphasize that other important factors such as the environment play an important role in disease pathogenesis. While microbiota as an environment factor to some cancers accept widespread attention, if microbiota also as a risk factor for TC, it is worthy to be considered.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –50 healthy volunteers were included in the healthy control group |
| Thyroid cancer group | – | –50 patients of thyroid cancer were included |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were included according to the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Aged 18 to 65 years
- Patients of thyroid cancer
Key exclusion criteria (11 listed)
- Pregnancy
- Lactation
- Cigarette smoking
- Alcohol addiction
- Hypertension
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 |
|---|---|---|
| Other | Thyroid cancer group |
Primary outcome
Transcriptional changes in gut microbiota
Time frame: Baseline
The microbiota measured by 16S rRNA gene
1 secondary outcome
Metabolic changes in gut microbiota
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- 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.
Yunwei Wei study director
First Affiliated Hospital of Harbin Medical University
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 2 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: finished, as of the sponsor's last update on 27 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional changes in gut microbiota (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.