Intestinal Microbiota and Thyroid Cancer

Microbiota Clinical Trial

Official title:

Correlation Study of Thyroid Cancer and Intestinal Microbiota

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543891
• Other study ID #: Yunwei Wei 2018-05-20
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: September 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 65 years

• Patients of thyroid cancer

Exclusion Criteria:

• Pregnancy

• Lactation

• Cigarette smoking

• Alcohol addiction

• Hypertension

• Diabetes mellitus

• 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

Related Conditions & MeSH terms

• Microbiota
• Thyroid Neoplasms

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptional changes in gut microbiota	The microbiota measured by 16S rRNA gene	Baseline
Secondary	Metabolic changes in gut microbiota	Metabolic changes measured by metabonomics analysis	Baseline