Role of Preoperative Serum Thyroglobulin Level to Differe... | NCT06157632

Studies
Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules

NCT06157632

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 6, 2023Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Level of Thyrogobulin in Different Thyroid Nodules

Interventions

Thyriodectomy

Countries

Not provided

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2023Estimated

Primary Completion Date

Nov 18, 2024Estimated

Completion Date

Nov 25, 2024Estimated

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 6, 2023Actual

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

Dec 4, 2023

Last Update Posted Date

Dec 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Gamal Hussein Hasan, Resident doctor at general surgery departement assiut university, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules

Detailed Description

Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound.

The gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study is done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.

Metabolism of thyroglobulin occurs in the liver and via thyroid gland and recycling of the protein takes place. Circulating thyroglobulin features a half lifetime of 65 hours. Following thyroidectomy, it will take many weeks before thyroglobulin levels become undetectable. After thyroglobulin levels become undetectable (following thyroidectomy), levels are often serially monitored.

A subsequent elevation of the thyroglobulin level is an indicator of recurrence of papillary or follicular thyroid carcinoma. Hence, thyroglobulin levels in the blood are mainly used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic carcinoma.

Therefore, this study tries to evaluate the association between the preoperative thyroglobulin levels and thyroid carcinoma proven by post-operative histopathology.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with thyoid nodules	Other	Patients with thyroid nodules that will do thyroidectomy	Procedure: Thyriodectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyriodectomy	Procedure	Thyroidectomy	Patients with thyoid nodules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules	Use of serum thyroglobulin to differentiate between different thyroid nodules preoperoperatively	Two year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 15 to 70 years old
patients with solitary thyroid nodules
pateints who are fit for surgeries

Exclusion Criteria:

1_patients who are unfit for surgeries

2_ age below 15 years and above 70 years old

3-patients with thyroid nodule receiving drugs that affect thyroglobulin level as iodine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Patients with thyroid nodules

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Gamal, Master	Contact	01062142009		Gamal8431@gmail.com
Mohamed Hasan, Prof	Contact	0 122 3971586		mh.osman@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohamed Baker, Prof	Assiut University	Study Director
Mahmoud Thabet, Assistant.prof	Assiut University	Study Director

Locations

Not provided