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Status unknownNCT05124938Updated Nov 18, 2021

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

An observational study in Thyroid Cancer, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-18.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
1 Year to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Thyroid Cancer

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Keywords

  • CA19-9
03

In context

Thyroid Neoplasms

819 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's planned enrollment of 120 is below the median of 160 across 267 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

  • Inclusion Criteria: Patients with malignant thyroid tumors.
  • Exclusion criteria: Patients with benign thyroid tumors ,Patients not known to have pancreatic disease.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testLaboratory 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.

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What researchers measure

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.

    Time frame: within 3 days after collection of the samples

07

Study locations

1 site
  • Sohag faculty of medicine
    Sohag, Egypt
    • Marwa Ashraf, resident · Contact · Marwaelkabsh@gmail.com · 01004771988
    • Laila Mohammed, lecturer · Contact · 01002976973
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2021; primary completion for Jun 2022, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2021
First posted
Nov 18, 2021
StartEst.
Dec 1, 2021
Primary completionEst.
Jun 1, 2022
CompletionEst.
Dec 1, 2022
Last update
Nov 18, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05124938
Lead sponsor
Sohag University
Responsible party
Marwa Ashraf Ahmed (Resident of clinical and chemical pathology, Sohag University) — Principal investigator
First posted
Nov 18, 2021
Start date
Dec 1, 2021 (estimated)
Primary completion
Jun 1, 2022 (estimated)
Completion
Dec 1, 2022 (estimated)
Last update
Nov 18, 2021

Study contacts

Marwa Ashraf
Contact
Marwaelkabsh@gmail.com
01004771988
Marwa Ashraf
principal investigator · Sohag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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