Incidence of Thyroid Cancer in Long Standing MNGNCT06405919
Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study
An observational study of Incidence of Thyroid Cancer in Long Standing MNG, run by University of Khartoum at 1 site in Sudan.
Trial summary
To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incidence of Thyroid Cancer in Long Standing MNG
- What is being tested?
- Histopathology
- How many people
- 160 participants
- Where
- 1 siteSudan
- Study dates
- 1 Mar 2017to 30 Sep 2018
- 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: Patients with long standing goitres presenting for surgery in Khartoum Teaching Hospital March 2017-September 2018
Who may be able to join
- All patients with long standing goitres of 10 years or more
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery.
Read the detailed description
This is a prospective cohort study The objective is to determine the incidence of cancer in patients with long standing goitres( more than 10 years ) who present for surgery in Khartoum Teaching Hopspital - Sudan.
Introduction: goitre is endemic in Sudan with prevalence ranging between 5-42% in different regions of the country. Patients are referred for surgery only if they develop pressure symptoms.
The incidence of thyroid carcinoma is high in endemic goitrous areas. Determining the risk of cancer in patient with long standing goitres may help in early early referral and early surgical intervention.
Methods: This is prospective cohort study including 160 patients with long standing goitrers of 10 years or more who presented from March 2017 to September 2017 to Khartoum Teaching Hospital-Sudan
- Being tested
- Histopathology
- Keywords
- : goitre, long standing, malignant risk, incidental.
- Medical subject headings
- Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistopathologyDiagnostic test
Thyroidectomy for patients and histological examination of specimen to determine incidence of malignancy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with goitres 10 years or more | Patients with long standing multinodular goitres of 10years or more presenting to surgical unit in Khartoum Teaching Hospital -Sudan. Checking incidence of malignancy in this group. Receives: Diagnostic Test: Histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of malignancy
Rate of malignancy in resected goitre specimens
Measured: March 2017-September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Mar 2017
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Thyroid Cancer in Long Standing MNGStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Sudan Medical Specialization Board
- Responsible party
- Principal investigator, Seifeldin Mahdi, University of Khartoum
- Investigators
- Mohamed Elmakki Abdella, MS,FRCSI, Study director, University of Khartoum -Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405919
- Sponsor's protocol ID
- UofK
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Malignancy in Endemic Long Standing Nodular Goitres: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06405919
- Acronym / sponsor ID
- UofK
- Keywords
- : goitre, long standing, malignant risk, incidental.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Sudan Medical Specialization Board
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 May 2024 (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.
To determine the incidence of thyroid cancer in patients with long standing goitres presenting for surgery.
Detailed description
This is a prospective cohort study The objective is to determine the incidence of cancer in patients with long standing goitres( more than 10 years ) who present for surgery in Khartoum Teaching Hopspital - Sudan.
Introduction: goitre is endemic in Sudan with prevalence ranging between 5-42% in different regions of the country. Patients are referred for surgery only if they develop pressure symptoms.
The incidence of thyroid carcinoma is high in endemic goitrous areas. Determining the risk of cancer in patient with long standing goitres may help in early early referral and early surgical intervention.
Methods: This is prospective cohort study including 160 patients with long standing goitrers of 10 years or more who presented from March 2017 to September 2017 to Khartoum Teaching Hospital-Sudan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with goitres 10 years or more | – | Diagnostic Test: HistopathologyPatients with long standing multinodular goitres of 10years or more presenting to surgical unit in Khartoum Teaching Hospital -Sudan. Checking incidence of malignancy in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with long standing goitres presenting for surgery in Khartoum Teaching Hospital March 2017-September 2018
Key inclusion criteria (1 listed)
- All patients with long standing goitres of 10 years or more
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| HistopathologyThyroidectomy for patients and histological examination of specimen to determine incidence of malignancy. | Diagnostic test | Patients with goitres 10 years or more |
Primary outcome
Rate of malignancy
Time frame: March 2017-September 2018
Rate of malignancy in resected goitre specimens
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 9 May 2024.
- Individual participant dataSharing planned: Undecided
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.
Mohamed Elmakki Abdella, MS,FRCSI study director
University of Khartoum -Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence of Thyroid Cancer in Long Standing MNG, run by University of Khartoum at 1 site in Sudan.
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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Rate of malignancy (time frame: March 2017-September 2018). 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 9 May 2024.