Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 6:50 AM
Study NCT ID:
NCT04376203
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome and Papillary Thyroid Microcarcinoma
Sponsor:
Organization:
Raw JSON
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Epub 2018 Feb 1."}, {'pmid': '22972508', 'type': 'BACKGROUND', 'citation': 'Zhao Q, Ming J, Liu C, Shi L, Xu X, Nie X, Huang T. Multifocality and total tumor diameter predict central neck lymph node metastases in papillary thyroid microcarcinoma. Ann Surg Oncol. 2013 Mar;20(3):746-52. doi: 10.1245/s10434-012-2654-2. Epub 2012 Sep 13.'}, {'pmid': '24969306', 'type': 'BACKGROUND', 'citation': 'Zhou L, Li X, Ahmed A, Wu D, Liu L, Qiu J, Yan Y, Jin M, Xin Y. Gut microbe analysis between hyperthyroid and healthy individuals. Curr Microbiol. 2014 Nov;69(5):675-80. doi: 10.1007/s00284-014-0640-6. Epub 2014 Jun 27.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with indication for surgery for thyroid disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are going to have surgery for some thyroid disease, benign or malignant\n\nExclusion Criteria:\n\n* Recent, less than 3 months, infection of any system\n* Receiving antibiotic or antiviral medication in the previous trimester\n* Patient with chronic virus or bacterial infection\n* Patient with dermatological disease'}, 'identificationModule': {'nctId': 'NCT04376203', 'briefTitle': 'Microbiome and Papillary Thyroid Microcarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Ioannina'}, 'officialTitle': 'What is the Relation of Microbiome to Papillary Thyroid Microcarcinoma Development?', 'orgStudyIdInfo': {'id': 'Endocrine surgery Unit UOI 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'any patient with indications for thyroidectomy other than confirmed preoperative cancer', 'interventionNames': ['Procedure: Thyroidectomy']}, {'label': 'Thyroid microcarcinoma', 'description': 'either preoperative detection or random finding after thyroidectomy of another indication.', 'interventionNames': ['Procedure: Thyroidectomy']}], 'interventions': [{'name': 'Thyroidectomy', 'type': 'PROCEDURE', 'description': 'Typical Thyroidectomy', 'armGroupLabels': ['Control', 'Thyroid microcarcinoma']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'STEFANOS STEFANOU, Specialist', 'role': 'CONTACT', 'email': 'stefanousurgery@gmail.com', 'phone': '+306944983533'}, {'name': 'George Gogos Pappas, Specialist', 'role': 'CONTACT', 'email': 'pappasg8@gmail.com', 'phone': '+306973397398'}], 'overallOfficials': [{'name': 'KONSTANTINOS VLACHOS, Associate Professor of Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Ioannina'}, {'name': 'IOANNIS KOUTELIDAKIS, Associate Professor of Surgery', 'role': 'STUDY_CHAIR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Available in one year and for 3 years long', 'ipdSharing': 'YES', 'description': 'all data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Stefanos Stefanou', 'investigatorAffiliation': 'University of Ioannina'}}}}