ThyroidNCT04763122
Thyroid Cancer in United Arab Emirates
An observational study of Thyroid and Cancer, run by Tawam Hospital.
Trial summary
The main objective of the study is to assess the trend of clinicopathological features and treatment modalities in patients with thyroid cancer in the largest oncology center in the United Arab Emirates (UAE). Read more about this study
- Who is it for?
- Any age
- What is being tested?
- not applicable as it is a retrospective study
- How many people
- 762 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with Thyroid Cancer presenting to Tawam Hospital during the period of September 2008 and December 2018. Those with incorrect pathological diagnosis, incomplete data, or noninvasive follicular type PTC were excluded.
Who may be able to join
- All patients with Thyroid Cancer presenting to Tawam Hospital during the period of September 2008 and December 2018.
Who cannot join
- Patients with inadequate data, noninvasive follicular type PTC and incorrect pathological diagnosis,
About this study
Official title: Decline in Radioiodine Use But Not Total Thyroidectomy in Thyroid Cancer Patients Treated in United Arab Emirates- A Retrospective Study
The main objective of the study is to assess the trend of clinicopathological features and treatment modalities in patients with thyroid cancer in the largest oncology center in the United Arab Emirates (UAE).
Read the 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.
- Being tested
- not applicable as it is a retrospective study
- Keywords
- Malignancy, Radioactive iodine, total thyroidectomy, Thyroid Cancer
- Medical subject headings
- Thyroid Diseases, Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable as it is a retrospective studyOther
It is a retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Thyroid Cancer Cases | Not described Receives: Other: not applicable as it is a retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinicopathological features
Assess clinicopathological features of thyroid cancer patients
Measured: September 2008- December 2018
Extent of surgery
Assess extent of surgery in thyroid cancer patients and changes over time
Measured: September 2008- December 2018
Use of RAI
Evaluate the use of RAI in thyroid cancer patients and assess predictors of RAI Rx
Measured: September 2008- December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startSep 2008
- Primary completionDec 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tawam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled M Aldahmani, Tawam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763122
- Sponsor's protocol ID
- SA/AJ/562
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decline in Radioiodine Use But Not Total Thyroidectomy in Thyroid Cancer Patients Treated in United Arab Emirates- A Retrospective Study
- ClinicalTrials.gov ID
- NCT04763122
- Acronym / sponsor ID
- SA/AJ/562
- Keywords
- Malignancy, Radioactive iodine, total thyroidectomy, Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Tawam HospitalUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to assess the trend of clinicopathological features and treatment modalities in patients with thyroid cancer in the largest oncology center in the United Arab Emirates (UAE).
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid Cancer Cases | – | Other: not applicable as it is a retrospective study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Thyroid Cancer presenting to Tawam Hospital during the period of September 2008 and December 2018. Those with incorrect pathological diagnosis, incomplete data, or noninvasive follicular type PTC were excluded.
Key inclusion criteria (1 listed)
- All patients with Thyroid Cancer presenting to Tawam Hospital during the period of September 2008 and December 2018.
Key exclusion criteria (1 listed)
- Patients with inadequate data, noninvasive follicular type PTC and incorrect pathological diagnosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not applicable as it is a retrospective studyIt is a retrospective study | Other | Thyroid Cancer Cases |
Primary outcome
Clinicopathological features
Time frame: September 2008- December 2018
Assess clinicopathological features of thyroid cancer patients
Extent of surgery
Time frame: September 2008- December 2018
Assess extent of surgery in thyroid cancer patients and changes over time
Use of RAI
Time frame: September 2008- December 2018
Evaluate the use of RAI in thyroid cancer patients and assess predictors of RAI Rx
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Cancer, run by Tawam Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinicopathological features (time frame: September 2008- December 2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.