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

NCT05124938 | Unknown

• 1 other identifier: Soh-Med-21-10-11
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer

Keywords

CA19-9

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1

Healthy individuals

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.

Group 2

patients with localized thyroid malignancy

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.

Group 3

patients with metastatic thyroid malignancy

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.

Interventions

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. DIAGNOSTIC_TEST

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group1: age and sex matched healthy control individuals. Group2: patients with localized thyroid malignancy. Group3: patients with metastatic thyroid malignancy.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Marwa Ashraf

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Ashraf

CONTACT

01004771988; Marwaelkabsh@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of clinical and chemical pathology

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)