Assessment of CA 19-9 in Patients' With Thyroid Malignancies

Thyroid Cancer Clinical Trial

Official title:

Assessment of CA19-9 in Patients' With Thyroid Malignancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05124938
• Other study ID #: Soh-Med-21-10-11
• Status: Not yet recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Sohag University
• Contact: Marwa Ashraf
• Phone: 01004771988
• Email: Marwaelkabsh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.Incidence of thyroid cancer in north Africa about 2.8% of all new cancer cases with mortality rate about 0.73%.Thyroid malignancies are classified into different groups as follows:Papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,Follicular thyroid cancer that forms about 10-15% of all thyroid cancers,Anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,Medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma.

Medullary thyroid carcinoma (MTC) is a rare disease, and its classic tumor marker is calcitonin. However, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (CA19-9), and its role as a marker of worse prognosis has been questioned.

Description:

Thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.Incidence of thyroid cancer in north Africa about 2.8% of all new cancer cases with mortality rate about 0.73%.Thyroid malignancies are classified into different groups as follows:Papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,Follicular thyroid cancer that forms about 10-15% of all thyroid cancers,Anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,Medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma.

Medullary thyroid carcinoma (MTC) is a rare disease, and its classic tumor marker is calcitonin. However, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (CA19-9), and its role as a marker of worse prognosis has been questioned.

CA19-9 was originally described as a gastrointestinal system and pancreas specific tumor marker. Immunohistochemical studies have demonstrated that CA19-9 is expressed in both differentiated and anaplastic thyroid carcinomas. Increased serum levels of CA 19-9 were reported in few patients with anaplastic thyroid cancer.The idea that CA19.9 could be predictive of mortality in MTC stems from early research which showed that serum creatinine and increased carcinoembryonic antigen levels were not important markers in MTC, but that Ca19.9, which is secreted in MTC, was significantly associated with progressive disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

• Inclusion Criteria: Patients with malignant thyroid tumors.

• Exclusion criteria: Patients with benign thyroid tumors ,Patients not known to have pancreatic disease.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• Laboratory investigations for control: a-Complete blood count. b-Liver function test. c-kidney function test. d-thyroid-stimulating hormone,T3 and T4. e-Assessment of levels of CA19-9.
a-Complete blood count. b-Liver function test. c-kidney function test d-thyroid-stimulating hormone,T3 and T4. e-Assessment of levels of CA19-9.

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of CA19-9 in patients' with thyroid malignancies.	Measurement of serum levels of CA19-9 in patients' with thyroid malignancies by chemiluminescence methods of study on I flash device.	within 3 days after collection of the samples