Clinical trial · Observational
Active Surveillance Program in Thyroid Nodules
Outcomes of a 5-Year Active Surveillance Program in Bethesda IV-VI Thyroid Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Overview This study focuses on thyroid nodules, specifically the Bethesda IV-VI categories, which have uncertain or suspicious malignancy. The idea is to observe and monitor these nodules instead of opting for immediate surgery, a practice known as active surveillance. The main goal of active surveillance is to avoid unnecessary surgeries, which can lead to complications like nerve damage or hypoparathyroidism. Problem and Objectives Thyroid nodules in these Bethesda categories can be cancerous, but not all require immediate removal. Active surveillance tracks nodule growth and other changes using regular ultrasounds and clinical checkups. This approach is gaining popularity, especially in Japan, Europe, and the U.S., but there's still a need for more data, particularly in Latin America. The primary objectives of the study are: General: To describe the clinical and imaging characteristics of patients with Bethesda IV-VI nodules under active surveillance. Specific: To measure surgery rates, reasons for surgery, and how long patients can avoid surgery. Methodology This study is a multicenter historical cohort study, which will look at patients treated from 2019 to 2023 in different hospitals. Patients included in the study are those with Bethesda IV-VI thyroid nodules, who are over 18 and have been managed without immediate thyroid surgery. Data will be collected from medical records and imaging reports, and patients will be followed up to document any changes in their nodules, including growth or metastasis. Expected Impact The study aims to determine whether active surveillance can safely delay or avoid surgery for selected patients. It could have a significant impact on clinical decision-making, improving patient outcomes and reducing unnecessary surgeries, especially within the Colombian healthcare system. If successful, this approach could reduce costs and improve the quality of life for patients with thyroid nodules. Ethical Considerations The study will follow ethical guidelines, ensuring patient confidentiality and classifying the research as "no-risk," meaning it involves minimal risk to the participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bethesda IV-VI report
- description
- thyroid nodules who underwent FNAC with a Bethesda IV-VI report
- interventionNames
- Other: Active surveillance
Primary outcomes (1)
- measure
- surgery-free survival.
- timeFrame
- 24 months
- description
- Time elapsed from the start of follow-up until surgery or last visit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with thyroid nodules and FNAC with a report corresponding to Bethesda category IV-VI, treated at the following health centers: HUSVF, HAMA, Center of Excellence in Head and Neck Diseases - CEXCA, Somer Clinic. 2. Patients classified as low-risk tumors (intrathyroidal, with no evidence of locoregional or distant metastasis). 3. Patients not subjected to thyroidectomy as the initial treatment. Exclusion Criteria: * 1\. Patients with a second head and neck cancer. 2. Patients with clinical or imaging evidence of thyroid malignancy with lymph node or distant metastasis confirmed by pathology.
References
Publications (12)
- BACKGROUNDSmulever A, Pitoia F. Active surveillance in papillary thyroid carcinoma: not easily accepted but possible in Latin America. Arch Endocrinol Metab. 2019 Sep 2;63(5):462-469. doi: 10.20945/2359-3997000000168. eCollection 2019. PMID 31482955
- BACKGROUNDRosario PW, Mourao GF, Calsolari MR. Active Surveillance in Adults with Low-Risk Papillary Thyroid Microcarcinomas: A Prospective Study. Horm Metab Res. 2019 Nov;51(11):703-708. doi: 10.1055/a-1015-6684. Epub 2019 Nov 4. PMID 31683339
- BACKGROUNDGarcia-Lozano CA, Sanabria A. Preliminary Report of Active Surveillance as a Conservative Strategy for Bethesda IV Thyroid Nodules. Thyroid. 2023 Jan;33(1):126-128. doi: 10.1089/thy.2022.0296. Epub 2023 Jan 4. No abstract available. PMID 36254389
- BACKGROUNDSanabria A. Active Surveillance in Thyroid Microcarcinoma in a Latin-American Cohort. JAMA Otolaryngol Head Neck Surg. 2018 Oct 1;144(10):947-948. doi: 10.1001/jamaoto.2018.1663. PMID 30178005
- BACKGROUNDSanabria A. Experience with Active Surveillance of Thyroid Low-Risk Carcinoma in a Developing Country. Thyroid. 2020 Jul;30(7):985-991. doi: 10.1089/thy.2019.0522. Epub 2020 Feb 20. PMID 31950887
- BACKGROUNDHaugen 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
- BACKGROUNDMolinaro E, Campopiano MC, Pieruzzi L, Matrone A, Agate L, Bottici V, Viola D, Cappagli V, Valerio L, Giani C, Puleo L, Lorusso L, Piaggi P, Torregrossa L, Basolo F, Vitti P, Tuttle RM, Elisei R. Active Surveillance in Papillary Thyroid Microcarcinomas is Feasible and Safe: Experience at a Single Italian Center. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e172-80. doi: 10.1210/clinem/dgz113.