Microbiome and Papillary Thyroid Microcarcinoma

Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04376203
• Other study ID #: Endocrine surgery Unit UOI 1
• Status: Not yet recruiting
• Start date: July 27, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2020
• Source: University of Ioannina
• Contact: STEFANOS STEFANOU, Specialist
• Phone: +306944983533
• Email: stefanousurgery[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiome
• Papillary Thyroid Microcarcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Thyroidectomy
Typical Thyroidectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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