NCT03543891

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
Last Updated

June 27, 2018

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

May 21, 2018

Last Update Submit

June 25, 2018

Conditions

Keywords

Gut microbiota16S rRNA geneThyroid cancerMetabonomics

Outcome Measures

Primary Outcomes (1)

  • Transcriptional changes in gut microbiota

    The microbiota measured by 16S rRNA gene

    Baseline

Secondary Outcomes (1)

  • Metabolic changes in gut microbiota

    Baseline

Study Arms (2)

Control group

50 healthy volunteers were included in the healthy control group

Thyroid cancer group

50 patients of thyroid cancer were included

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients were included according to the inclusion and exclusion criteria

You may qualify if:

  • Aged 18 to 65 years
  • Patients of thyroid cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Yunwei Wei

    First Affiliated Hospital of Harbin Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

September 1, 2017

Primary Completion

February 28, 2018

Study Completion

April 30, 2018

Last Updated

June 27, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations