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NCT Number: NCT06292988

Predictive Factors for Medullary Thyroid Cancer Aggressiveness

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

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Key information

Conditions

Medullary Thyroid Cancer Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Total thyroidectomy

Procedure

Total thyroidectomy

Primary outcomes

  1. 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

  2. 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

  3. Distant metastasis

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

    Liver and lung metastasis

Secondary outcomes

  1. Nuclear atypia as histological predictor of aggressiveness

    Time frame: The pathology report is held immediately after surgery

    nuclear atypia

  2. Amyloid as histological predictor of aggressiveness

    Time frame: The pathology report is held immediately after surgery

    amyloid

  3. Immunohistochemistry as histological predictor of aggressiveness

    Time frame: The pathology report is held immediately after surgery

    immunohistochemistry

  4. Desmoplasia as histological predictor of aggressiveness

    Time frame: The pathology report is held immediately after surgery

    desmoplasia

  5. 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

  6. 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

  7. White blood cell as Biochemical predictor of aggressiveness

    Time frame: pre and postoperative laboratory exams up to 1 year postoperatively

    white blood cell count

  8. Platelet count as Biochemical predictor of aggressiveness

    Time frame: pre and postoperative laboratory exams up to 1 year postoperatively

    platelet count

  9. CEA drop as Biochemical cure marker

    Time frame: up to 1 year postoperatively

    CEA drop levels

  10. Calcitonin drop as Biochemical cure marker

    Time frame: up to 1 year postoperatively

    calcitonin drop levels

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Predective Factors for Tumor Aggressiveness in Medullary Thyroid Cancer

Acronym: MYELO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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