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临床试验/NCT04376203
NCT04376203Unknown不适用

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

University of Ioannina0 个研究点目标入组 40 人开始时间: 2020年7月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Type of microbiome in peripheral blood sample of a patient with papillary thyroid microcarcinoma

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefanos Stefanou

MD

University of Ioannina

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Microbiome and Papillary Thyroid Microcarcinoma | 临床试验