Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microbiome and Papillary Thyroid Microcarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04376203
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Stefanos Stefanou, 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

Condition or disease Intervention/treatment
Papillary Thyroid Microcarcinoma Microbiome Procedure: Thyroidectomy

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: What is the Relation of Microbiome to Papillary Thyroid Microcarcinoma Development?
Estimated Study Start Date : July 27, 2020
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients with indication for surgery for thyroid disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376203


Contacts
Layout table for location contacts
Contact: STEFANOS STEFANOU, Specialist +306944983533 stefanousurgery@gmail.com
Contact: George Gogos Pappas, Specialist +306973397398 pappasg8@gmail.com

Sponsors and Collaborators
University of Ioannina
Investigators
Layout table for investigator information
Study Chair: KONSTANTINOS VLACHOS, Associate Professor of Surgery University of Ioannina
Study Chair: IOANNIS KOUTELIDAKIS, Associate Professor of Surgery Aristotle University Of Thessaloniki
Publications:

Layout table for additonal information
Responsible Party: Stefanos Stefanou, MD, University of Ioannina
ClinicalTrials.gov Identifier: NCT04376203    
Other Study ID Numbers: Endocrine surgery Unit UOI 1
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Available in one year and for 3 years long

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefanos Stefanou, University of Ioannina:
Microbiome
Papillary Thyroid Microcarcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Papillary
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms