Is Desmoplastic Stromal Reaction Useful to Modulate Lymph Node Dissection in Sporadic Medullary Thyroid Carcinoma?

NCT06243965 | Completed

• 1 other identifier: 5547
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

The oncologic benefit of lateral neck dissection (LND) during index operation for sporadic medullary thyroid carcinoma (MTC) basing on basal calcitonin (bCT) levels has been questioned due to the potential post-operative complications. This study aims to evaluate desmoplastic reaction (DSR), as predictor of nodal metastases, for definition of surgical strategy. Data from pathological report of MTC after operations between 1997 and 2022 were collected. The primary endpoint of the study was evaluating the risk factors for nodal metastases. The secondary endpoints analyzed the correlations between DSR and nodal metastases and the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of DSR for nodal metastases.

Conditions

Medullary Thyroid Cancer; Medullary Carcinoma; Medullary Tumor; Medullary Neoplasms; Desmoplasia; Desmoplastic; Desmoplastic Reaction; Lymph Node Metastasis; Lymph Node Disease

Keywords

medullary thryoid carcinoma; desmoplasia; lateral neck dissection

Outcome Measures

Primary Outcomes (1)

• Risk factors for nodal metastases

  The primary endpoint of the study consists in the evaluation of risk factors for nodal metastases in patients with histopathologic report of medullary thryoid carcinoma

  January 1997-December 2022

Secondary Outcomes (1)

• Correlations between desmoplastic stromal reaction and nodal metastases

  January 1997-December 2022

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adults patients who underwent index procedure between January 1997 and December 2022 in our center for sporadic unifocal MTC whose specimens were retrospectively re-evaluated by an expert endocrine pathologist (E.D.R.) for DSR were candidates for inclusion.

You may not qualify if:

• hereditary MTC
• sporadic multifocal MTC
• index operation in another center
• incidental diagnosis of MCT after less than total thyroidectomy and bilateral central neck dissection
• less than 6-months-follow-up
• patients \< 18 years old

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Carcinoma, Medullary; Brain Stem Neoplasms; Fibrosis; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Neoplastic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 6, 2024
• Study Start: January 1, 1997
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

IT (1)