Calcitonin in Needle Wash Using Electrochemiluminescence Method For Diagnosis Of Medullary Thyroid Carcinoma.

NCT06067594 | Completed

• 1 other identifier: 17-042
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Medullary thyroid carcinoma (MTC) is a tumor originating from parafollicular C cells of the thyroid. (1) Representing 1 to 7% of all thyroid carcinoma cases (2, 3, 4). It can occur in two clinical forms, the sporadic or non-hereditary, in 75-80% of patients, and the hereditary form in the remaining 20-25%. It can be part of different clinical syndromes depending on the organs involved: Multiple Endocrine Neoplasia type 2A (MEN2A), Multiple Endocrine Neoplasia type 2B (MEN2B) and Familial Medullary Thyroid Carcinoma (FCM) whose clinical expression is only CMT. A distinctive characteristic of this tumor is its capacity to secrete calcitonin (CT), which, measured in serum, sanctions suspicion of this pathology (5-8) leading to diagnostic studies to confirm CMT. For the preoperative diagnosis of thyroid nodules, ultrasound-guided fine-needle aspiration cytology (FNAC) is a useful and safe procedure; however, its sensitivity to exclude CMT is low (9-15). In 2015, a meta-analysis of 15 studies (16) found that the accuracy of FNAC in diagnosing CMT was around 50%. For this reason, other studies have indicated that the measurement of calcitonin in the fine-needle lavage aspirate fluid of thyroid nodules (CT-guided FNAC), which have suspected medullary carcinoma, can significantly improve the accuracy in the diagnosis of MTC (17 -19). Therefore, clinical practice guidelines recommend its determination in patients with suspected MTC (1,2). The diagnostic importance of pre-surgical medullary carcinoma lies mainly in two points: first, it changes the surgical approach of the patients, and second, it allows one to rule out associated pathologies such as hyperparathyroidism and pheochromocytoma, which are associated when the entity is hereditary. The performance of CT-guided FNAC by the chemiluminescent (CL) method has been widely disseminated. However, to the best of our knowledge, to date there are no data available on the appropriate cut-off value of CT-guided FNAC with calcitonin electrochemiluminescence (ECL) immunometric assay method. As previously stated, it is of particular interest to determine the calcitonin cut-off point in needle washing by electrochemiluminescence method that allows diagnosing medullary carcinoma. Clarifying this point allows improving the approach to patients in whom medullary carcinoma is suspected. This work seeks to determine the cut-off point of CT-guided FNAC for the diagnosis of CMT with the ECL assay method.

Conditions

Medullary Thyroid Carcinoma; Nodular Goiter

Keywords

calcitonin; calcitonin in washout fluid of fine needle aspiration

Outcome Measures

Primary Outcomes (2)

• medullary carcinoma

  The diagnosis of medullary carcinoma is defined according to guidelines of the American Society of Pathologists that uses the Pathological Anatomy service as a diagnostic basis.

  01.03.2018 to May 31, 2022.

• to assess the diagnostic accuracy of FNA-Ctn using an ECLIA for confirmation and localization of MTC, searching for a fixed FNA-Ctn threshold.

  Sensitivity, specificity, and the area under the receiving operator curve (AUROC) were calculated for patients and for the total number of thyroid nodules

  01.03.2018 to May 31, 2022.

Study Arms (2)

MTC cases

• Cases: Patients who meet the above inclusion and exclusion criteria and have a diagnosis of medullary carcinoma by histology

Diagnostic Test: Fine Needle Aspiration Cytology (FNAC) procedure+calcitonin measurement

Controls

Controls: Patients who meet the above inclusion and exclusion criteria and do not have a diagnosis of medullary carcinoma by histology.

Diagnostic Test: Fine Needle Aspiration Cytology (FNAC) procedure+calcitonin measurement

Interventions

Fine Needle Aspiration Cytology (FNAC) procedure+calcitonin measurement DIAGNOSTIC_TEST

Fine needle aspiration (FNA) nodule biopsy: FNA is performed on each patient as long as ATA guideline criteria is met. In case of suspicion of medullary carcinoma, in search of a nodule or medullary focus, FNA will be performed on all non-cystic or spongiform nodules larger than 0.8 cm.

Also known as: FNA-Ctn

Controls; MTC cases

Eligibility Criteria

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

Study Population

This was a case-control study nested on a prospective multicenter cohort of patients with nodular or multinodular goiter, with normal, or elevated serum Ctn, and thyroidectomy indication.

Sponsors & Collaborators

• Austral University, Argentina: lead

Study Sites (1)

Hospital Universitario Austral

Pilar, Buenos Aires, 1633, Argentina

Location

Related Publications (8)

• Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

  PMID: 26462967 RESULT

• Wells SA Jr, Asa SL, Dralle H, Elisei R, Evans DB, Gagel RF, Lee N, Machens A, Moley JF, Pacini F, Raue F, Frank-Raue K, Robinson B, Rosenthal MS, Santoro M, Schlumberger M, Shah M, Waguespack SG; American Thyroid Association Guidelines Task Force on Medullary Thyroid Carcinoma. Revised American Thyroid Association guidelines for the management of medullary thyroid carcinoma. Thyroid. 2015 Jun;25(6):567-610. doi: 10.1089/thy.2014.0335.

  PMID: 25810047 RESULT

• Bugalho MJ, Santos JR, Sobrinho L. Preoperative diagnosis of medullary thyroid carcinoma: fine needle aspiration cytology as compared with serum calcitonin measurement. J Surg Oncol. 2005 Jul 1;91(1):56-60. doi: 10.1002/jso.20269.

  PMID: 15999359 RESULT

• Kudo T, Miyauchi A, Ito Y, Yabuta T, Inoue H, Higashiyama T, Tomoda C, Hirokawa M, Amino N. Serum calcitonin levels with calcium loading tests before and after total thyroidectomy in patients with thyroid diseases other than medullary thyroid carcinoma. Endocr J. 2011;58(3):217-21. doi: 10.1507/endocrj.k10e-359. Epub 2011 Feb 24.

  PMID: 21358115 RESULT

• Boi F, Maurelli I, Pinna G, Atzeni F, Piga M, Lai ML, Mariotti S. Calcitonin measurement in wash-out fluid from fine needle aspiration of neck masses in patients with primary and metastatic medullary thyroid carcinoma. J Clin Endocrinol Metab. 2007 Jun;92(6):2115-8. doi: 10.1210/jc.2007-0326. Epub 2007 Apr 3.

  PMID: 17405835 RESULT

• Trimboli P, Mian C, Piccardo A, Treglia G. Diagnostic tests for medullary thyroid carcinoma: an umbrella review. Endocrine. 2023 Aug;81(2):183-193. doi: 10.1007/s12020-023-03326-6. Epub 2023 Mar 6.

  PMID: 36877452 RESULT

• Kihara M, Hirokawa M, Kudo T, Hayashi T, Yamamoto M, Masuoka H, Higashiyama T, Fukushima M, Ito Y, Miya A, Miyauchi A. Calcitonin measurement in fine-needle aspirate washout fluid by electrochemiluminescence immunoassay for thyroid tumors. Thyroid Res. 2018 Oct 30;11:15. doi: 10.1186/s13044-018-0059-4. eCollection 2018.

  PMID: 30450128 RESULT

• Cavallo AC, Pitoia F, Roberti J, Brenzoni P, Lencioni M, Jaroslavsky MJ, Spengler E, Voogd A, Firpo C, Saco P, Pinero F, Negueruela M. Optimizing Diagnostic Accuracy of Fine Needle Aspiration Biopsy Calcitonin Measurements in Detecting Medullary Thyroid Carcinoma. Thyroid. 2024 Feb;34(2):186-196. doi: 10.1089/thy.2023.0313. Epub 2024 Jan 12.

  PMID: 38047535 DERIVED

MeSH Terms

Conditions

Carcinoma, Medullary; Goiter, Nodular

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; Goiter; Thyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: March 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: June 1, 2022
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: data made available ( starting 6 months after publication).
• Access Criteria: solicitado por la revista en la cual se publique el artículo

Locations

AR (1)