Risk of Malignancy in Endemic Long Standing Nodular Goitr... | NCT06405919

Studies
Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study

NCT06405919

Sponsor

University of Khartoum

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Incidence of Thyroid Cancer in Long Standing MNG

Interventions

Histopathology

Countries

Sudan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

May 4, 2024

First Submission Date that Met QC Criteria

May 4, 2024

First Posted Date

May 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2024

Last Update Posted Date

May 9, 2024Actual

Name	Class
Sudan Medical Specialization Board	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery.

Detailed Description

This is a prospective cohort study The objective is to determine the incidence of cancer in patients with long standing goitres( more than 10 years ) who present for surgery in Khartoum Teaching Hopspital - Sudan.

Introduction: goitre is endemic in Sudan with prevalence ranging between 5-42% in different regions of the country. Patients are referred for surgery only if they develop pressure symptoms.

The incidence of thyroid carcinoma is high in endemic goitrous areas. Determining the risk of cancer in patient with long standing goitres may help in early early referral and early surgical intervention.

Methods: This is prospective cohort study including 160 patients with long standing goitrers of 10 years or more who presented from March 2017 to September 2017 to Khartoum Teaching Hospital-Sudan

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with goitres 10 years or more		Patients with long standing multinodular goitres of 10years or more presenting to surgical unit in Khartoum Teaching Hospital -Sudan. Checking incidence of malignancy in this group.	Diagnostic Test: Histopathology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Histopathology	Diagnostic Test	Thyroidectomy for patients and histological examination of specimen to determine incidence of malignancy.	Patients with goitres 10 years or more

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of malignancy	Rate of malignancy in resected goitre specimens	March 2017-September 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with long standing goitres of 10 years or more

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with long standing goitres presenting for surgery in Khartoum Teaching Hospital March 2017-September 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamed Elmakki Abdella, MS,FRCSI	University of Khartoum -Faculty of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine University of Khartoum		Khartoum		11111	Sudan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006042	Goiter

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided