Microbiome and Papillary Thyroid Microcarcinoma

June 28, 2020 updated by: Stefanos Stefanou, University of Ioannina

What is the Relation of Microbiome to Papillary Thyroid Microcarcinoma Development?

It has been shown that gut microbiome and microbiome metabolism can regulate or control the initiation of a cancer process. To the best of the investigators knowledge, no study has directly shown the relationship of the thyroid microcarcinoma to the human microbiome. In this work, the aim is to detect the microbiome in peripheral blood in a patient with a thyroid gland carcinoma, and to correlate it with the disease, compared to the microbiome of a group of patients who did not find another thyroid gland carcinoma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Measurements of biological markers and tumor cell motility may be useful in predicting early whether a papillary thyroid microcarcinoma (PTMC) will develop to invasive carcinoma. Ideally, patients at high risk of progression may undergo immediate surgery instead of active surveillance and those with a very low likelihood of tumor progression may be included in an active surveillance protocol. Future research should focus on the development of new predictive early markers of papillary thyroid carcinoma during patient follow-up. From the above, it is clear the need to develop a new marker that raises the suspicion of possible thyroid microcarcinoma, if it is not preoperatively detected by the needle biopsy method and the patient has the indication for surgery for another benign thyroid disease. To date, there are no absolute biological and clinical parameters distinguishing a low risk from a high risk PTMC. If the fine needle aspiration shows stage V and VI Bethesda classification, and there is a high suspicion of PTMC, then questions such as the extent of the surgery, lobectomy or total thyroidectomy are beginning to be raised. The next dilemma is lymphadenectomy. The dilemma is greater if there are enlarged cervical lymph nodes (diameter over 1 cm in diameter of the small axis) and subsequently micromestases are confirmed. Another entity is when the cervical lymph nodes are not pathologically enlarged. This clinical situation is often emphasized as 60-80% of PTMC patients have metastases. By correlating a possible difference in the microbiome of a participants peripheral blood preoperatively, together with the imaging data, there may have been another marker of early PTMC detection and patient management planning respectively.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: George Gogos Pappas, Specialist
  • Phone Number: +306973397398
  • Email: pappasg8@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with indication for surgery for thyroid disease

Description

Inclusion Criteria:

  • Patients who are going to have surgery for some thyroid disease, benign or malignant

Exclusion Criteria:

  • Recent, less than 3 months, infection of any system
  • Receiving antibiotic or antiviral medication in the previous trimester
  • Patient with chronic virus or bacterial infection
  • Patient with dermatological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
any patient with indications for thyroidectomy other than confirmed preoperative cancer
Procedure: Thyroidectomy
Typical Thyroidectomy
Thyroid microcarcinoma
either preoperative detection or random finding after thyroidectomy of another indication.
Procedure: Thyroidectomy
Typical Thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma
Time Frame: preoperatively periferal blood collection, perioperatively periferal blood colection
Microbiome in a sample of peripheral blood in a patient with PTMC and to correlate it with the disease as a diagnostic marker compared to patients without any type of thyroid cancer.
preoperatively periferal blood collection, perioperatively periferal blood colection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Investigators

  • Study Chair: KONSTANTINOS VLACHOS, Associate Professor of Surgery, University of Ioannina
  • Study Chair: IOANNIS KOUTELIDAKIS, Associate Professor of Surgery, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 27, 2020

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 28, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endocrine surgery Unit UOI 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all data

IPD Sharing Time Frame

Available in one year and for 3 years long

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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