Predictive Factors for Medullary Thyroid Cancer Aggressiveness (MYELO)

January 2, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Salzburg, Austria
        • Department of Surgery, Saint John of God Hospital, Salzburg, Austria
  • Belgium
      • Bruxelles, Belgium
        • Saint Luc, University Clouvain, Belgium
  • Brazil
      • Santa Cruz Do Sul, Brazil
        • Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil
  • Bulgaria
      • Sofia, Bulgaria
        • University Clinic of Surgery, University Hospital "Lozenec"
  • China
      • Hong Kong, China
        • Chinese University of Hong Kong
  • Colombia
      • Manizales, Colombia
        • Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia
  • Croatia
      • Zagreb, Croatia
        • the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery
  • France
      • Brest, France
        • Head and Neck Surgery, Brest University Hospital, Brest, France
      • Poitiers, France
        • The University Hospital of Poitiers, France
  • Greece
      • Athens, Greece
        • Thyroid Surgery Clinic IKE, Athens, Greece
      • Larissa, Greece
        • ENT Department University Hospital of Larissa
      • Patra, Greece
        • Department of Surgery, General University Hospital of Patras
      • Thessaloníki, Greece
        • Aristotle University Of Thessaloniki
      • Thessaloníki, Greece
        • Gennimatas General Hospital
  • India
      • Bhubaneswar, India
        • Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar
      • Coimbatore, India
        • KMCH and KMCH Comprehensive Cancer Center
      • Madurai, India
        • Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences
      • New Delhi, India
        • Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital
      • Vijayawada, India
        • Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India
  • Iraq
      • Erbil, Iraq
        • University of Sulaimani | UNIVSUL ,Department of Surgery, Kurdistan
  • Italy
      • Domodossola, Italy
        • ASL VCO - San Biagio Hospital - Domodossola (VB) - Italy
      • Genoa, Italy
        • Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy
      • Milan, Italy
        • Asst Santi Paolo e Carlo - Ospedale Polo Universitario San Paolo, Milan, Italy
      • Roma, Italy
        • UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS
      • Trieste, Italy
        • Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy
      • Verona, Italy
        • Department of Surgery and Oncology, Endocrine Surgery Unit, Verona University Hospital
  • Jordan
      • Zarqa, Jordan
        • Hashemite University of Zarqa
  • Morocco
      • Marrakech, Morocco
        • Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco
  • Poland
      • Gdańsk, Poland
        • Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk
  • Serbia
      • Belgrad, Serbia
        • Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade
  • Slovakia
      • Bratislava, Slovakia
        • Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases
      • Bratislava, Slovakia
        • Department of oncological surgery, St. Elisabeth cancer Institute
  • Spain
      • Barcelona, Spain
        • Hospital Clinic (Barcelona, Spain)
      • Córdoba, Spain
        • Universitaria de Cordoba
      • Málaga, Spain
        • Hospital Regional de Malaga
      • Vigo, Spain
        • Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain
  • Switzerland
      • Bern, Switzerland
        • Bern University Hospital
      • 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
  • Turkey
      • Ankara, Turkey
        • Ankara University Faculty of Medicine, Department of Endocrine Surgery
      • Istanbul, Turkey
        • Acibadem MAA University
      • Istanbul, Turkey
        • Cerrahpasa medical faculty endocrine surgery department
      • Istanbul, Turkey
        • Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey
  • Ukraine
      • Kyiv, Ukraine
        • Endocrine surgeon-consultant, International medical center "CITIDOCTOR"
  • United States
    • Oregon
      • Oregon City, Oregon, United States, 97239
        • Oregon Health & Science University, Oregon
  • Vietnam
      • Việt Trì, Vietnam
        • Department of Radiology, Thien Hanh Hospital, Buon Ma Thuot, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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