The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 Cm Papillary Thyroid Carcinoma
Launched by LEONARDO ROSSI · Mar 20, 2025
Trial Information
Current as of May 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to explore the potential benefits and drawbacks of a surgical procedure called prophylactic central compartment neck dissection in patients with a type of thyroid cancer known as papillary thyroid carcinoma (PTC). The study focuses on patients whose tumors are between 2 to 4 centimeters in size and who do not show any signs of lymph node involvement or spread to other parts of the body before surgery. Participants will be randomly assigned to receive either total thyroidectomy (removal of the thyroid gland) alone or total thyroidectomy combined with the neck dissection procedure. The goal is to understand whether adding the neck dissection improves outcomes for patients.
To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of papillary thyroid carcinoma through a specific needle test, and show no signs of lymph node or distant metastasis (spread of cancer). Unfortunately, those with different types of thyroid cancer or evidence of metastasis during surgery cannot participate. If you join the trial, you can expect thorough monitoring and care throughout the process as researchers gather important information to help improve treatment for future patients with this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \[15\]);
- • 2. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
- • 3. no clinical evidence of distant metastasis at diagnosis;
- • 4. age ≥ 18 years.
- Exclusion Criteria:
- • 1. histotypes other than PTC;
- • 2. evidence of lymph node metastases during surgery even if not previously diagnosed;
- • 3. presence of distant metastasis.
About Leonardo Rossi
Leonardo Rossi is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and ethical standards, Mr. Rossi oversees clinical studies that span various therapeutic areas, ensuring robust data collection and analysis. His extensive experience in clinical operations and strategic planning enables the successful execution of trials, fostering collaboration with healthcare professionals and regulatory bodies. Through a patient-centered approach, Leonardo Rossi aims to contribute significantly to the development of safe and effective treatments that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported