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Medullary Thyroid CancerMYELONCT06292988

Predictive Factors for Medullary Thyroid Cancer Aggressiveness

An observational study of Medullary Thyroid Cancer, run by Aristotle University Of Thessaloniki at 46 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Medullary Thyroid Cancer
What is being tested?
Total Thyroidectomy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
46 sitesin 24 countries
Study dates
1 Mar 2024to 15 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Age < 18 years

Trial locations and contacts

46 sites in 24 countries.

46 sites in 24 countries

Italy6 sites

  • ASL VCO - San Biagio Hospital - Domodossola (VB) - Italy

    Domodossola

  • Dipartimento di Scienze Chirurgiche (DISC), University of Genoa, Italy

    Genoa

  • Asst Santi Paolo e Carlo - Ospedale Polo Universitario San Paolo, Milan, Italy

    Milan

  • UOC Chirurgia Endocrina e Metabolica, Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma

  • Department of Medical and Surgical Sciences, University of Trieste, Cattinara Teaching Hospital, Trieste, Italy

    Trieste

  • Department of Surgery and Oncology, Endocrine Surgery Unit, Verona University Hospital

    Verona

Other trials in Italy

Greece5 sites

  • Thyroid Surgery Clinic IKE, Athens, Greece

    Athens

  • ENT Department University Hospital of Larissa

    Larissa

  • Department of Surgery, General University Hospital of Patras

    Pátrai

  • Aristotle University of Thessaloniki

    Thessaloniki

  • Gennimatas General Hospital

    Thessaloniki

Other trials in Greece

India5 sites

  • Department of ENT-Head and Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar

    Bhubaneswar

  • KMCH and KMCH Comprehensive Cancer Center

    Coimbatore

  • Department of Endocrine and Breast Surgery at Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Madurai

  • Department of Surgery, Maulana Azad Medical College & Lok Nayak Hospital

    New Delhi

  • Endocrine and Metabolic Surgery, Bhargav Endocrine Hospital, Vijayawada, India

    Vijayawada

Other trials in India

Spain4 sites

  • Hospital Clinic (Barcelona, Spain)

    Barcelona

  • Universitaria de Cordoba

    Córdoba

  • Hospital Regional de Málaga

    Málaga

  • Department of General and Digestive Surgery, Division of Endocrine Surgery, Complexo Hospitalario Universitario de Vigo, Vigo, Spain

    Vigo

Other trials in Spain

Turkey (Türkiye)4 sites

  • Ankara University Faculty of Medicine, Department of Endocrine Surgery

    Ankara

  • Acibadem MAA University

    Istanbul

  • Cerrahpasa medical faculty endocrine surgery department

    Istanbul

  • Department of Endocrin Pathology Unit, University of Health Sciences, Faculty of Medicine, Bakırköy Dr Sadi Konuk Training and Research Hospital, Istanbul, Turkey

    Istanbul

Other trials in Turkey (Türkiye)

France2 sites

  • Head and Neck Surgery, Brest University Hospital, Brest, France

    Brest

  • The University Hospital of Poitiers, France

    Poitiers

Other trials in France

Slovakia2 sites

  • Comenius University in Bratislava, Department of Paediatric Surgery, National Institute of Children's Diseases

    Bratislava

  • Department of oncological surgery, St. Elisabeth cancer Institute

    Bratislava

Other trials in Slovakia

Switzerland2 sites

  • Bern University Hospital

    Bern

  • Geneva University Hospital

    Geneva

Other trials in Switzerland

United States1 site

  • Oregon Health & Science University, Oregon

    Oregon City, Oregon, 97239

Other trials in United States

Austria1 site

  • Department of Surgery, Saint John of God Hospital, Salzburg, Austria

    Salzburg

Other trials in Austria

Belgium1 site

  • Saint Luc, University Clouvain, Belgium

    Brussels

Other trials in Belgium

Brazil1 site

  • Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil

    Santa Cruz do Sul

Other trials in Brazil

Bulgaria1 site

  • University Clinic of Surgery, University Hospital "Lozenec"

    Sofia

Other trials in Bulgaria

China1 site

  • Chinese University of Hong Kong

    Hong Kong

Other trials in China

Colombia1 site

  • Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia

    Manizales

Other trials in Colombia

Croatia1 site

  • the University Hospital Center Sestre milosrdnice, Zagreb, Croatia, Department of Otorhinolaryngology and Head and Neck Surgery

    Zagreb

Other trials in Croatia

Iraq1 site

  • University of Sulaimani | UNIVSUL ,Department of Surgery, Kurdistan

    Erbil

Other trials in Iraq

Jordan1 site

  • Hashemite University of Zarqa

    Zarqa

Other trials in Jordan

Morocco1 site

  • Hepatobiliairy and endocrine surgery, Ibn Sina Hospital, Medical School of Medecine Rabat, Mohamed Vth University of Rabat Morocco

    Marrakesh

Other trials in Morocco

Poland1 site

  • Division of General, Endocrine and Transplant Surgery, Medical University of Gdańsk

    Gdansk

Other trials in Poland

Serbia1 site

  • Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Medical School, University of Belgrade

    Belgrade

Other trials in Serbia

Thailand1 site

  • Division of Endocrinology and Metabolism Department of Medicine Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok, Thailand

    Bangkok

Other trials in Thailand

Ukraine1 site

  • Endocrine surgeon-consultant, International medical center "CITIDOCTOR"

    Kyiv

Other trials in Ukraine

Vietnam1 site

  • Department of Radiology, Thien Hanh Hospital, Buon Ma Thuot, Vietnam

    Viet Tri

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Being tested
Total Thyroidectomy
Medical subject headings
Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total ThyroidectomyProcedure or surgery

    Total thyroidectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central lymph node metastasis

    Central neck compartment lymph node metastasis

    Measured: Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively

  2. Lateral lymph node metastasis

    Lateral neck compartment lymph node metastasis

    Measured: Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively

  3. Distant metastasis

    Liver and lung metastasis

    Measured: Number of distant Metastasis found in preoperative imaging studies or up to 1 year postoperatively

Secondary outcomes (10)

  1. Nuclear atypia as histological predictor of aggressiveness

    nuclear atypia

    Measured: The pathology report is held immediately after surgery

  2. Amyloid as histological predictor of aggressiveness

    amyloid

    Measured: The pathology report is held immediately after surgery

  3. Immunohistochemistry as histological predictor of aggressiveness

    immunohistochemistry

    Measured: The pathology report is held immediately after surgery

  4. Desmoplasia as histological predictor of aggressiveness

    desmoplasia

    Measured: The pathology report is held immediately after surgery

  5. CEA as Biochemical predictor of aggressiveness

    Carcinoembryonic antigen (CEA) preoperatively and up to 1 year postoperatively

    Measured: pre and postoperative laboratory exams up to 1 year postoperatively

  6. Calcitonin as Biochemical predictor of aggressiveness

    calcitonin levels preoperatively and up to 1 year postoperatively

    Measured: pre and postoperative laboratory exams up to 1 year postoperatively

  7. White blood cell as Biochemical predictor of aggressiveness

    white blood cell count

    Measured: pre and postoperative laboratory exams up to 1 year postoperatively

  8. Platelet count as Biochemical predictor of aggressiveness

    platelet count

    Measured: pre and postoperative laboratory exams up to 1 year postoperatively

  9. CEA drop as Biochemical cure marker

    CEA drop levels

    Measured: up to 1 year postoperatively

  10. Calcitonin drop as Biochemical cure marker

    calcitonin drop levels

    Measured: up to 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start1 Mar 2024
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292988
Sponsor's protocol ID
MYELO
Acronym
MYELO
Status last verified
Mar 2024
First submitted
19 Feb 2024
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Medullary Thyroid Cancer, run by Aristotle University Of Thessaloniki at 46 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Italy, Greece, India, Spain, Turkey (Türkiye) and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central lymph node metastasis (time frame: Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06292988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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