Medullary Thyroid Carcinoma Clinical Trial
Official title:
Optimizing Diagnostic Accuracy of Fine Needle Aspiration Biopsy Calcitonin Measurements in Detecting Medullary Thyroid Carcinoma
NCT number | NCT06067594 |
Other study ID # | 17-042 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | June 1, 2022 |
Verified date | October 2023 |
Source | Austral University, Argentina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 155 |
Est. completion date | June 1, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria:Patients = 18 years of age, with nodular or multinodular goiter who are undergoing surgery, with normal or elevated serum calcitonin and/or with suspected CMT due to RET mutation from 3/1/2018 to 5/31/2022 will be selected according to inclusion criteria. - Exclusion Criteria:Patients who do not have a remaining puncture sample, without serum calcitonin, not referred to surgery or those who are lost upon follow-up, will be excluded. - |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Universitario Austral | Pilar | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Austral University, Argentina |
Argentina,
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 — View Citation
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. — View Citation
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 — View Citation
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. 20 — View Citation
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. E — View Citation
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. — View Citation
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 Medu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. |
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