Microbiome and Papillary Thyroid Microcarcinoma

NCT04376203 | Unknown DMC

• 1 other identifier: Endocrine surgery Unit UOI 1
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Papillary Thyroid Microcarcinoma; Microbiome

Keywords

Microbiome; Papillary Thyroid Microcarcinoma

Outcome Measures

Primary Outcomes (1)

• Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma

  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

Study Arms (2)

Control

any patient with indications for thyroidectomy other than confirmed preoperative cancer

Procedure: Thyroidectomy

Thyroid microcarcinoma

either preoperative detection or random finding after thyroidectomy of another indication.

Procedure: Thyroidectomy

Interventions

Thyroidectomy PROCEDURE

Typical Thyroidectomy

Control; Thyroid microcarcinoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with indication for surgery for thyroid disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

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MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Interventions

Thyroidectomy

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• KONSTANTINOS VLACHOS, Associate Professor of Surgery

  University of Ioannina

  STUDY CHAIR

• IOANNIS KOUTELIDAKIS, Associate Professor of Surgery

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Central Study Contacts

STEFANOS STEFANOU, Specialist

CONTACT

+306944983533; stefanousurgery@gmail.com

George Gogos Pappas, Specialist

CONTACT

+306973397398; pappasg8@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 6, 2020
• Study Start: July 27, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2023
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available in one year and for 3 years long