Predictive Factors for Medullary Thyroid Cancer Aggressiveness (MYELO)

March 1, 2024 updated by: Papavramidis Theodossis, Aristotle University Of Thessaloniki

Predective Factors for Tumor Aggressiveness in Medullary Thyroid Cancer

This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival. The predictive factors included in this study are central and lateral compartment lymph node metastases as well as distant metastasis up to 1 year postoperatively, while biochemical predictors (meaning ratios such as lymphocyte to monocyte ratio etc and CEA and calcitonin drop levels) and histological predictors (such as nuclear atypia, amyloid, immunohistochemistry, desmoplasia) are included as secondary outcomes. In this study , patients >18 years old that underwent surgery for medullary thyroid cancer (total thyroidectomy, completion thyroidectomy) +/- central/lateral neck dissection) will be enrolled.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Salzburg, Austria
        • Department of Surgery, Saint John of God Hospital, Salzburg, Austria
        • Contact:
  • Belgium
  • Brazil
      • Santa Cruz Do Sul, Brazil
        • Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil
        • Contact:
  • Bulgaria
      • Sofia, Bulgaria
        • University Clinic of Surgery, University Hospital "Lozenec"
        • Contact:
  • China
  • Colombia
      • Manizales, Colombia
        • Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia
        • Contact:
  • Croatia
      • Zagreb, Croatia
        • the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery
        • Contact:
  • France
      • Brest, France
      • Poitiers, France
        • The University Hospital of Poitiers, France
  • Greece
      • Athens, Greece
        • Thyroid Surgery Clinic IKE, Athens, Greece
        • Contact:
        • Sub-Investigator:
          • Lampros Karakozis
      • Larissa, Greece
      • Patra, Greece
      • Thessaloníki, Greece
        • Aristotle University Of Thessaloniki
      • Thessaloníki, Greece
        • Gennimatas General Hospital
        • Contact:
        • Sub-Investigator:
          • Nikolaos Voloudakis
  • India
      • Bhubaneswar, India
        • Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar
        • Contact:
      • Coimbatore, India
      • Madurai, India
        • Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences
        • Contact:
      • New Delhi, India
        • Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital
        • Contact:
      • Vijayawada, India
        • Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India
        • Contact:
  • Iraq
      • Erbil, Iraq
  • Italy
      • Domodossola, Italy
      • Genoa, Italy
        • Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy
        • Contact:
      • Milan, Italy
      • Roma, Italy
        • UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS
        • Contact:
        • Sub-Investigator:
          • Francesco Pennestri
      • Trieste, Italy
        • Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy
        • Contact:
      • Verona, Italy
  • Jordan
  • Morocco
      • Marrakech, Morocco
        • Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco
        • Contact:
  • Poland
      • Gdańsk, Poland
        • Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk
        • Contact:
  • Serbia
      • Belgrad, Serbia
        • Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade
        • Contact:
  • Slovakia
      • Bratislava, Slovakia
        • Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases
        • Contact:
      • Bratislava, Slovakia
        • Department of oncological surgery, St. Elisabeth cancer Institute
        • Contact:
  • Spain
      • Barcelona, Spain
        • Hospital Clinic (Barcelona, Spain)
        • Contact:
        • Sub-Investigator:
          • Òscar Vidal Perez
        • Sub-Investigator:
          • Marti Manyalich
      • Córdoba, Spain
      • Málaga, Spain
        • Hospital Regional De Malaga
        • Contact:
        • Sub-Investigator:
          • Marta Iturregui Guevara
      • Vigo, Spain
        • Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain
        • Contact:
  • Switzerland
      • Bern, Switzerland
        • Bern University Hospital
        • Contact:
        • Sub-Investigator:
          • Nesti Cedric
      • Geneva, Switzerland
        • Geneva University Hospital
  • Thailand
      • Bangkok, Thailand
        • Division of Endocrinology and Metabolism Department of Medicine Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok, Thailand
        • Contact:
  • Turkey
      • Ankara, Turkey
        • Ankara University Faculty of Medicine, Department of Endocrine Surgery
        • Contact:
      • Istanbul, Turkey
        • Acibadem MAA University
      • Istanbul, Turkey
        • Cerrahpasa medical faculty endocrine surgery department
        • Contact:
      • Istanbul, Turkey
        • Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey
        • Contact:
  • Ukraine
      • Kyiv, Ukraine
        • Endocrine surgeon-consultant, International medical center "CITIDOCTOR"
        • Contact:
  • United States
    • Oregon
      • Oregon City, Oregon, United States, 97239
        • Oregon Health & Science University, Oregon
        • Contact:
  • Vietnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients >18 years old who underwent surgery for medullary thyroid cancer are enrolled in this study

Description

Inclusion Criteria:

  • Patients who underwent thyroidectomy for medullary thyroid cancer (total thyroidectomy, completion thyroidectomy) +/- central/lateral neck dissection

Exclusion Criteria:

  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central lymph node metastasis
Time Frame: Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Central neck compartment lymph node metastasis
Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Lateral lymph node metastasis
Time Frame: Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Lateral neck compartment lymph node metastasis
Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Distant metastasis
Time Frame: Number of distant Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Liver and lung metastasis
Number of distant Metastasis found in preoperative imaging studies or up to 1 year postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nuclear atypia as histological predictor of aggressiveness
Time Frame: The pathology report is held immediately after surgery
nuclear atypia
The pathology report is held immediately after surgery
Amyloid as histological predictor of aggressiveness
Time Frame: The pathology report is held immediately after surgery
amyloid
The pathology report is held immediately after surgery
Immunohistochemistry as histological predictor of aggressiveness
Time Frame: The pathology report is held immediately after surgery
immunohistochemistry
The pathology report is held immediately after surgery
Desmoplasia as histological predictor of aggressiveness
Time Frame: The pathology report is held immediately after surgery
desmoplasia
The pathology report is held immediately after surgery
CEA as Biochemical predictor of aggressiveness
Time Frame: pre and postoperative laboratory exams up to 1 year postoperatively
Carcinoembryonic antigen (CEA) preoperatively and up to 1 year postoperatively
pre and postoperative laboratory exams up to 1 year postoperatively
Calcitonin as Biochemical predictor of aggressiveness
Time Frame: pre and postoperative laboratory exams up to 1 year postoperatively
calcitonin levels preoperatively and up to 1 year postoperatively
pre and postoperative laboratory exams up to 1 year postoperatively
White blood cell as Biochemical predictor of aggressiveness
Time Frame: pre and postoperative laboratory exams up to 1 year postoperatively
white blood cell count
pre and postoperative laboratory exams up to 1 year postoperatively
Platelet count as Biochemical predictor of aggressiveness
Time Frame: pre and postoperative laboratory exams up to 1 year postoperatively
platelet count
pre and postoperative laboratory exams up to 1 year postoperatively
CEA drop as Biochemical cure marker
Time Frame: up to 1 year postoperatively
CEA drop levels
up to 1 year postoperatively
Calcitonin drop as Biochemical cure marker
Time Frame: up to 1 year postoperatively
calcitonin drop levels
up to 1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Theodossis Papavramidis, Prof, 1st Propedeutic Department of Surgery, AHEPA University Hospital of Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYELO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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