MedDataX Logo

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

NCT ID: NCT05124938

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

CA19-9

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Healthy individuals

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.

Intervention Type 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 2

patients with localized thyroid malignancy

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.

Intervention Type 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 3

patients with metastatic thyroid malignancy

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.

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Inclusion Criteria: Patients with malignant thyroid tumors.

Exclusion Criteria

* Exclusion criteria: Patients with benign thyroid tumors ,Patients not known to have pancreatic disease.
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marwa Ashraf Ahmed

Resident of clinical and chemical pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marwa Ashraf

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag faculty of medicine

Sohag, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marwa Ashraf

Role: CONTACT

Phone: 01004771988

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marwa Ashraf, resident

Role: primary

Laila Mohammed, lecturer

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-21-10-11

Identifier Type: -

Identifier Source: org_study_id