## Protocol Section
### Identification Module
**NCT ID:** NCT06417463

**Brief Title:** Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules

**Official Title:** Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules

#### Organization Study ID Info
**ID:** Soh-Med-24-04-05MS
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2024-10-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-10-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sohag University

#### Responsible Party

**Investigator Affiliation:** Sohag University

**Investigator Full Name:** Keroless Nagy Boles

**Investigator Title:** resident at general surgery department sohag university hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then referred to FNA and follow up according to variable risk of maligneny.

**Detailed Description:** this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and Fine needle aspiration (FNA) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced.

### Conditions Module

**Conditions:**

- Thyroid Nodule

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** correlation between TIRADS and Bethesda scoring system (preoperative) and final histopathology (postoperative) in cases of thyroidectomy

**Name:** thyroidectomy opeartion

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** correlation between TIRADS and Behtesda scoring systems (preoperative) and final histopathology (post opeartive) in cases of thyroidectomy

**Measure:** managemnt thyroid nodules

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients will proved to have single or multinodular goitre thyroid nodules more than 1cm

Exclusion Criteria:

* thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy

**Healthy Volunteers:** True

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** patients will proved to have single or multinodular goitre \& patients with thyroid nodules more than 1 cm

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kerloesnagy@med.sohag.edu.eg

**Name:** kerloes N boulis, resident

**Phone:** 01287533690

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sohag

**Contacts:**

***Contact 1:***

- **Name:** Magdy M Amin, professor

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Sohag university Hospital

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** AlSaedi AH, Almalki DS, ElKady RM. Approach to Thyroid Nodules: Diagnosis and Treatment. Cureus. 2024 Jan 13;16(1):e52232. doi: 10.7759/cureus.52232. eCollection 2024 Jan.

**PMID:** 38352091

**Citation:** Bojunga J, Trimboli P. Thyroid ultrasound and its ancillary techniques. Rev Endocr Metab Disord. 2024 Feb;25(1):161-173. doi: 10.1007/s11154-023-09841-1. Epub 2023 Nov 10.

**PMID:** 37946091

**Citation:** Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.

**PMID:** 29091573

**Citation:** Pemayun TG. Current Diagnosis and Management of Thyroid Nodules. Acta Med Indones. 2016 Jul;48(3):247-257.

**PMID:** 27840362

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000013964

- Term: Thyroid Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M18986

- Name: Thyroid Nodule

- Relevance: HIGH

- As Found: Thyroid Nodules

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16723

- Name: Thyroid Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016606

- Term: Thyroid Nodule

- ID: D000013959

- Term: Thyroid Diseases

### Misc Info Module

- Version Holder: 2024-05-31
