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

November 6, 2021 updated by: Marwa Ashraf Ahmed, Sohag University

Assessment of CA19-9 in Patients' With Thyroid Malignancies

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag Faculty of Medicine
        • Contact:
        • Contact:
          • Laila Mohammed, lecturer
          • Phone Number: 01002976973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum levels of CA19-9 in patients' with thyroid malignancies.
Time Frame: within 3 days after collection of the samples
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Marwa Ashraf, Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 6, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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