Predictive Factors for Medullary Thyroid Cancer Aggressiveness

Completed

• Conditions: Medullary Thyroid Cancer

• Registration Number: NCT06292988
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief 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.

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 Timeline

• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-05
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Central lymph node metastasis	Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively	Central neck compartment lymph node metastasis
Lateral lymph node metastasis	Number of lymph node Metastasis found in preoperative imaging studies or up to 1 year postoperatively	Lateral neck compartment lymph node metastasis
Distant metastasis	Number of distant Metastasis found in preoperative imaging studies or up to 1 year postoperatively	Liver and lung metastasis

Secondary Outcome Measures

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

Trial Locations

Locations (46)

Oregon Health & Science University, Oregon; 🇺🇸 Oregon City, Oregon, United States

Department of Surgery, Saint John of God Hospital, Salzburg, Austria; 🇦🇹 Salzburg, Austria

Saint Luc, University Clouvain, Belgium; 🇧🇪 Bruxelles, Belgium

Head and Neck Surgery Department, Hospital Ana Nery, Santa Cruz do Sul, Brazil; 🇧🇷 Santa Cruz Do Sul, Brazil

University Clinic of Surgery, University Hospital "Lozenec"; 🇧🇬 Sofia, Bulgaria

Chinese University of Hong Kong; 🇨🇳 Hong Kong, China

Head and Neck Department Oncologos del Occidente, Universidad de Caldas, Manizales, Colombia; 🇨🇴 Manizales, Colombia

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

Head and Neck Surgery, Brest University Hospital, Brest, France; 🇫🇷 Brest, France

The University Hospital of Poitiers, France; 🇫🇷 Poitiers, France

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