Active Surveillance Program in Thyroid Nodules

NCT06653257 | Not Yet Recruiting

• 1 other identifier: 4
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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

Thyroid Nodule

Keywords

thyroid; nodule; bethesda; active surveillance

Outcome Measures

Primary Outcomes (1)

• surgery-free survival.

  Time elapsed from the start of follow-up until surgery or last visit

  24 months

Study Arms (1)

Bethesda IV-VI report

thyroid nodules who underwent FNAC with a Bethesda IV-VI report

Other: Active surveillance

Interventions

Active surveillance OTHER

a non-operative management strategy aimed at avoiding unnecessary surgery in patients with thyroid nodules with a cytopathological diagnosis of Bethesda IV-VI, who do not present clinical or imaging characteristics suggesting malignancy and/or aggressiveness.

Bethesda IV-VI report

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

Patients with thyroid nodules who underwent FNAC with a Bethesda IV-VI report

You may qualify if:

• 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.
• Patients classified as low-risk tumors (intrathyroidal, with no evidence of locoregional or distant metastasis).
• Patients not subjected to thyroidectomy as the initial treatment.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Centro de Excelencia en Enfermedades de Cabeza y Cuello: lead
• Hospital Alma Mater de Antioquia: collaborator
• Hospital San Vicente Fundación: collaborator
• Clinica Somer: collaborator

Study Sites (4)

Hospital Alma Mater de Antoquia

Medellín, Antioquia, 050010, Colombia

Location

Hospital San Vicente Fundacion

Medellín, Antioquia, 050010, Colombia

Location

Universidad de Antioquia

Medellín, 050021, Colombia

Location

Clinica Somer

Rionegro, Colombia

Location

Related Publications (12)

• Smulever 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 BACKGROUND

• Rosario 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 BACKGROUND

• Garcia-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 BACKGROUND

• Sanabria 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 BACKGROUND

• Sanabria 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 BACKGROUND

• 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 BACKGROUND

• Molinaro 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.

  PMID: 31652318 BACKGROUND

• Koot A, Soares P, Robenshtok E, Locati LD, de la Fouchardiere C, Luster M, Bongiovanni M, Hermens R, Ottevanger P, Geenen F, Bartѐs B, Rimmele H, Durante C, Nieveen-van Dijkum E, Stalmeier P, Dedecjus M, Netea-Maier R. Position paper from the Endocrine Task Force of the European Organisation for Research and Treatment of Cancer (EORTC) on the management and shared decision making in patients with low-risk micro papillary thyroid carcinoma. Eur J Cancer. 2023 Jan;179:98-112. doi: 10.1016/j.ejca.2022.11.005. Epub 2022 Nov 15.

  PMID: 36521335 BACKGROUND

• Sugitani I, Ito Y, Miyauchi A, Imai T, Suzuki S. Active Surveillance Versus Immediate Surgery: Questionnaire Survey on the Current Treatment Strategy for Adult Patients with Low-Risk Papillary Thyroid Microcarcinoma in Japan. Thyroid. 2019 Nov;29(11):1563-1571. doi: 10.1089/thy.2019.0211. Epub 2019 Sep 25.

  PMID: 31441377 BACKGROUND

• Brito JP, Ito Y, Miyauchi A, Tuttle RM. A Clinical Framework to Facilitate Risk Stratification When Considering an Active Surveillance Alternative to Immediate Biopsy and Surgery in Papillary Microcarcinoma. Thyroid. 2016 Jan;26(1):144-9. doi: 10.1089/thy.2015.0178. Epub 2015 Nov 5.

  PMID: 26414743 BACKGROUND

• Tuttle RM, Fagin JA, Minkowitz G, Wong RJ, Roman B, Patel S, Untch B, Ganly I, Shaha AR, Shah JP, Pace M, Li D, Bach A, Lin O, Whiting A, Ghossein R, Landa I, Sabra M, Boucai L, Fish S, Morris LGT. Natural History and Tumor Volume Kinetics of Papillary Thyroid Cancers During Active Surveillance. JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):1015-1020. doi: 10.1001/jamaoto.2017.1442.

  PMID: 28859191 BACKGROUND

• Ito Y, Miyauchi A, Kihara M, Higashiyama T, Kobayashi K, Miya A. Patient age is significantly related to the progression of papillary microcarcinoma of the thyroid under observation. Thyroid. 2014 Jan;24(1):27-34. doi: 10.1089/thy.2013.0367. Epub 2013 Nov 14.

  PMID: 24001104 BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Alvaro Sanabria

  Universidad de Antioquia

  STUDY DIRECTOR

Central Study Contacts

Alvaro Sanabria, Md, MSc, PhD

CONTACT

+57 60443113780; alvarosanabria@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

CO (4)