Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653257
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
Active Surveillance Program in Thyroid Nodules
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of a 5-Year Active Surveillance Program in Bethesda IV-VI Thyroid Nodules
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US but theres 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
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 US but theres 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None