Predictive Factors for Medullary Thyroid Cancer Aggressiveness

Medullary Thyroid Cancer Clinical Trial

— MYELO  

Official title:

Predective Factors for Tumor Aggressiveness in Medullary Thyroid Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292988
• Other study ID #: MYELO
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: March 2024
• Source: Aristotle University Of Thessaloniki
• Contact: Theodossis Papavramidis, Prof
• Phone: +306944536972
• Email: papavramidis[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Aggression
• Carcinoma, Neuroendocrine
• Medullary Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Total Thyroidectomy
Total thyroidectomy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Countries where clinical trial is conducted

United States,  Vietnam,  Austria,  Belgium,  Brazil,  Bulgaria,  China,  Colombia,  Croatia,  France,  Greece,  India,  Iraq,  Italy,  Jordan,  Morocco,  Poland,  Serbia,  Slovakia,  Spain,  Switzerland,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central lymph node metastasis	Central neck compartment lymph node metastasis	Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Primary	Lateral lymph node metastasis	Lateral neck compartment lymph node metastasis	Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Primary	Distant metastasis	Liver and lung metastasis	Number of distant Metastasis found in preoperative imaging studies or up to 1 year postoperatively
Secondary	Nuclear atypia as histological predictor of aggressiveness	nuclear atypia	The pathology report is held immediately after surgery
Secondary	Amyloid as histological predictor of aggressiveness	amyloid	The pathology report is held immediately after surgery
Secondary	Immunohistochemistry as histological predictor of aggressiveness	immunohistochemistry	The pathology report is held immediately after surgery
Secondary	Desmoplasia as histological predictor of aggressiveness	desmoplasia	The pathology report is held immediately after surgery
Secondary	CEA as Biochemical predictor of aggressiveness	Carcinoembryonic antigen (CEA) preoperatively and up to 1 year postoperatively	pre and postoperative laboratory exams up to 1 year postoperatively
Secondary	Calcitonin as Biochemical predictor of aggressiveness	calcitonin levels preoperatively and up to 1 year postoperatively	pre and postoperative laboratory exams up to 1 year postoperatively
Secondary	White blood cell as Biochemical predictor of aggressiveness	white blood cell count	pre and postoperative laboratory exams up to 1 year postoperatively
Secondary	Platelet count as Biochemical predictor of aggressiveness	platelet count	pre and postoperative laboratory exams up to 1 year postoperatively
Secondary	CEA drop as Biochemical cure marker	CEA drop levels	up to 1 year postoperatively
Secondary	Calcitonin drop as Biochemical cure marker	calcitonin drop levels	up to 1 year postoperatively