- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763122
Thyroid Cancer in United Arab Emirates
Decline in Radioiodine Use But Not Total Thyroidectomy in Thyroid Cancer Patients Treated in United Arab Emirates- A Retrospective Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of this study is to assess the trend of clinicopathological features and treatment modalities in patients with thyroid cancer (TC) in the largest oncology center in the United Arab Emirates (UAE).
This study was conducted in Tawam hospital (TWM), which provides tertiary care services to patients in the UAE. It is the only center delivering radioactive iodine (RAI) therapy and radiotherapy in Al Ain city. Most TC patients are followed in designated TC clinics within the endocrinology division or less commonly through other clinics (surgery, radiation, or medical oncology). The hospital runs monthly multidisciplinary team-based discussions on patients with TC, wherein decisions regarding RAI treatment and dose selection are determined jointly by nuclear medicine physicians and endocrinologists.
We retrospectively evaluated all patients with TC presenting to TWM during the period of September 2008 and December 2018. The beginning of data collection (September 2008) reflects the inception time of electronic medical records (EMRs) use in the hospital. Cases of TC were extracted from the EMRs using the International Classification of Disease 9 & 10 codes (193 & c73). Other variables were demographic information, year of diagnosis, type of TC, histopathological subtype, lymph node (LN) involvement, type of thyroid surgery, use of RAI treatment, and radiation therapy. The extent of surgery, the exact details of histopathology, and the RAI dose were retrieved from the respective specialty reports. Tumor staging was reported according to the 8th edition of the American joint committee on cancer (AJCC)/TNM staging system [16]. Those with incorrect pathological diagnosis, incomplete data, or noninvasive follicular type PTC were excluded.
The data were extracted using Microsoft Excel 2015 and imported into Stata 16.0 for statistical analysis. Continuous variables were described using means and standard deviations (±SD). Categorical variables were described as frequency distributions. Variables of clinical features and management were cross tabulated with the year of diagnosis and exact logistic and ordinal logistic regressions were performed to analyze the annual trend in features and management of TC as appropriate. The results of relative trend were reported as odds ratio (OR) with an overall ptrend. The OR=1 indicated no change over years, OR <1 indicated a decline, while OR >1 indicated an increase over years. Simple and multiple logistic regression analysis were performed to assess the unadjusted and adjusted association of management of TC (RAI, surgical management) with age, gender, nationality, year of diagnosis, tumor subtype, and other co-variates. The results of simple and multiple logistic regression were reported as odd ratios (OR) and adjusted odds ratios (AOR) respectively with their corresponding 95% confidence intervals (CI) and p-values.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with Thyroid Cancer presenting to Tawam Hospital during the period of September 2008 and December 2018.
Exclusion Criteria:
- Patients with inadequate data, noninvasive follicular type PTC and incorrect pathological diagnosis,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Thyroid Cancer Cases
|
It is a retrospective study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinicopathological features
Time Frame: September 2008- December 2018
|
Assess clinicopathological features of thyroid cancer patients
|
September 2008- December 2018
|
|
Extent of surgery
Time Frame: September 2008- December 2018
|
Assess extent of surgery in thyroid cancer patients and changes over time
|
September 2008- December 2018
|
|
Use of RAI
Time Frame: September 2008- December 2018
|
Evaluate the use of RAI in thyroid cancer patients and assess predictors of RAI Rx
|
September 2008- December 2018
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SA/AJ/562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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