Multiple Endocrine Neoplasia Type 1 (MEN-1)NCT05061784
Routine Transcervical Thymectomy in MEN-1 Patients
An observational study of Multiple Endocrine Neoplasia Type 1 (MEN-1) and Thymic Carcinoid, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Endocrine Neoplasia Type 1 (MEN-1), Thymic Carcinoid
- What is being tested?
- Routine thymectomy, which has been performed
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Jul 2021to 20 Aug 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.
Who may be able to join
- Studies including MEN-1 patients who underwent a routine thymectomy during parathyoidectomy
- We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.
Who cannot join
- We excluded reviews, letters, conference proceedings and non-English publications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revisiting the Evidence for Routine Transcervical Thymectomy for the Prevention of Thymic Carcinoid Tumours in MEN-1 Patients a Case Series
A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.
Read the detailed description
Introduction and Importance Malignant thymic carcinoids are uncommon but important entities among patients with multiple endocrine neoplasia type 1 (MEN-1). Current treatment guidelines advise the performance of a routine transcervical thymectomy (TCT) during parathyroidectomy, to prevent its development, although data on the yield of this prophylactic TCT is scarce. We aimed to revisit available literature to investigate and summarize the efficacy of routine TCT during neck exploration for parathyroidectomy, for the prevention of thymic carcinoid tumours among MEN-1 patients.
Methods A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.
- Being tested
- Routine thymectomy, which has been performed
- Keywords
- Routine transcervical thymectomy
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine thymectomy, which has been performedProcedure or surgery
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| MEN-1 patients who underwent routine thymectomy during parathyroidecotmy | A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids. Receives: Procedure: Routine thymectomy, which has been performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thyme carcinoid
Retrospective review of published studies
Measured: The timeframe will be from date of transcervical thymectomy until the date of documented diagnosis of diagnosis of thymic NET; progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start14 Jul 2021
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Endocrine Neoplasia Type 1 (MEN-1)Studies 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 only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajeev Parameswaran, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061784
- Sponsor's protocol ID
- exempt from review
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be collecting data; just studies that have already been published
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revisiting the Evidence for Routine Transcervical Thymectomy for the Prevention of Thymic Carcinoid Tumours in MEN-1 Patients a Case Series
- ClinicalTrials.gov ID
- NCT05061784
- Acronym / sponsor ID
- exempt from review
- Keywords
- Routine transcervical thymectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 30 Sep 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.
A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.
Detailed description
Introduction and Importance Malignant thymic carcinoids are uncommon but important entities among patients with multiple endocrine neoplasia type 1 (MEN-1). Current treatment guidelines advise the performance of a routine transcervical thymectomy (TCT) during parathyroidectomy, to prevent its development, although data on the yield of this prophylactic TCT is scarce. We aimed to revisit available literature to investigate and summarize the efficacy of routine TCT during neck exploration for parathyroidectomy, for the prevention of thymic carcinoid tumours among MEN-1 patients.
Methods A case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEN-1 patients who underwent routine thymectomy during parathyroidecotmy | – | Procedure: Routine thymectomy, which has been performedA case series was built after review of available literature by searching four databases (PubMed, Embase, Medline and Cochrane Library) for observational studies or case reports on routine prophylactic TCT for MEN-1 and the development of thymic carcinoids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We accepted randomized controlled trials or observational studies that included patients of any age who underwent a routine TCT in the setting for MEN-1, published as full-length articles in peer-reviewed journals, which mentioned data on thymic carcinoid tumours.
Key inclusion criteria (2 listed)
- Studies including MEN-1 patients who underwent a routine thymectomy during parathyoidectomy
Key exclusion criteria (1 listed)
- We excluded reviews, letters, conference proceedings and non-English publications.
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 |
|---|---|---|
| Routine thymectomy, which has been performedThere is no intervention | Procedure or surgery | MEN-1 patients who underwent routine thymectomy during parathyroidecotmy |
Primary outcome
Incidence of thyme carcinoid
Time frame: The timeframe will be from date of transcervical thymectomy until the date of documented diagnosis of diagnosis of thymic NET; progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.
Retrospective review of published studies
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 30 Sep 2021.
- Individual participant dataSharing planned: No. We will not be collecting data; just studies that have already been published
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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.
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 Multiple Endocrine Neoplasia Type 1 (MEN-1) and Thymic Carcinoid, run by National University Health System, Singapore at 1 site in Singapore.
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 2 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 30 Sep 2021. 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 Singapore. 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?
Incidence of thyme carcinoid (time frame: The timeframe will be from date of transcervical thymectomy until the date of documented diagnosis of diagnosis of thymic NET; progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.). 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 30 Sep 2021.