Microbiome and Papillary Thyroid Microcarcinoma

• Conditions: Microbiome; Papillary Thyroid Microcarcinoma
• Interventions: Procedure: Thyroidectomy

• Registration Number: NCT04376203
• Lead Sponsor: University of Ioannina

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

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 Timeline

• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Study First Posted: 2020-05-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-28
• Last Update Posted: 2020-06-30
• Study Start: 2020-07-27
• Primary Completion: 2022-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyroid microcarcinoma	Thyroidectomy	either preoperative detection or random finding after thyroidectomy of another indication.
Control	Thyroidectomy	any patient with indications for thyroidectomy other than confirmed preoperative cancer

Primary Outcome Measures

Name	Time	Method
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma	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.