Follicular Thyroid CancerNCT05052359
Aberrant Helix Pomatia Agglutinin Binding Glycan Expression in Follicular Thyroid Tumours
An observational study of Follicular Thyroid Cancer, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
Aberration of glycosylation is a hallmark of cancer cells, and plays an important role in oncogenesis and cancer progression, including metastasis. One of the markers of aberrant glycosylation (O-linked) is the binding of the lectin Helix pomatia agglutinin (HPA), which has been demonstrated in a wide range of human… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Thyroid Cancer
- What is being tested?
- Lectin-histochemistry retrospectively performed
- How many people
- 37 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2018to 1 Sep 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: For this retrospective cohort study, 37 patients who underwent thyroid surgery for a thyroid follicular neoplasm between 2005 and 2018 were identified from our institutional database and their tumours, characteristics and outcomes were analysed.
Who may be able to join
- For this retrospective cohort study, 37 patients who underwent thyroid surgery for a thyroid follicular neoplasm between 2005 and 2018 were identified from our institutional database and their tumours, characteristics and outcomes were analysed.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aberrant Helix Pomatia Agglutinin Binding Glycan Expression Changes With the Phenotype of Follicular Thyroid Tumours
Aberration of glycosylation is a hallmark of cancer cells, and plays an important role in oncogenesis and cancer progression, including metastasis. One of the markers of aberrant glycosylation (O-linked) is the binding of the lectin Helix pomatia agglutinin (HPA), which has been demonstrated in a wide range of human cancers, especially in tumours with a more aggressive phenotype. Data on the role of HPA within follicular neoplasms of the thyroid gland are currently lacking, therefore we sought to investigate possible changes in cell surface glycosylation associated with this type of neoplasms.
Read the detailed description
Lectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)). Sections were scored as positive when ≥5% of cancer cells labelled positive, and scored as negative when <5% labelled positive for HPA binding. Assessments of HPA-binding were performed by two observers, who were blinded to the identity of the sample, and their results were compared.
- Conditions
- Follicular Thyroid Cancer
- Being tested
- Lectin-histochemistry retrospectively performed
- Keywords
- Glycosylation
- Medical subject headings
- Adenocarcinoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lectin-histochemistry retrospectively performedDiagnostic test
Lectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)).
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity of HPA-labelling
Difference in HPA-binding among the phenotype of follicular lesions - percentage of positively labelled cancer cells: positive = ≥5% of cancer cells labelled positive
Measured: between 2005 and 2018
Secondary outcomes (1)
HPA-binding and other tumor markers
A Statistical association of HPA-binding positivity with other known adverse prognostic tumour markers (e.g. capsular or lymphovascular invasion) will be assessed using crosstabs and the non-parametric product limit method. Binary logistic regression models will be further developed using relevant clinicopathologic variables to determine their association with HPA-labelling to produce relative risks (odds ratios (ORs)).
Measured: between 2005 and 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jan 2018
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Thyroid CancerStudies 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
- Retrospective
- Enrolment
- 37 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
- NCT05052359
- Sponsor's protocol ID
- 2014/00378
- Other IDs
- 2014
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- 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 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aberrant Helix Pomatia Agglutinin Binding Glycan Expression Changes With the Phenotype of Follicular Thyroid Tumours
- ClinicalTrials.gov ID
- NCT05052359
- Acronym / sponsor ID
- 2014/00378
- Conditions
- Follicular Thyroid Cancer
- Keywords
- Glycosylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 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.
Aberration of glycosylation is a hallmark of cancer cells, and plays an important role in oncogenesis and cancer progression, including metastasis. One of the markers of aberrant glycosylation (O-linked) is the binding of the lectin Helix pomatia agglutinin (HPA), which has been demonstrated in a wide range of human cancers, especially in tumours with a more aggressive phenotype. Data on the role of HPA within follicular neoplasms of the thyroid gland are currently lacking, therefore we sought to investigate possible changes in cell surface glycosylation associated with this type of neoplasms.
Detailed description
Lectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)). Sections were scored as positive when ≥5% of cancer cells labelled positive, and scored as negative when <5% labelled positive for HPA binding. Assessments of HPA-binding were performed by two observers, who were blinded to the identity of the sample, and their results were compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For this retrospective cohort study, 37 patients who underwent thyroid surgery for a thyroid follicular neoplasm between 2005 and 2018 were identified from our institutional database and their tumours, characteristics and outcomes were analysed.
Key inclusion criteria (1 listed)
- For this retrospective cohort study, 37 patients who underwent thyroid surgery for a thyroid follicular neoplasm between 2005 and 2018 were identified from our institutional database and their tumours, characteristics and outcomes were analysed.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Lectin-histochemistry retrospectively performedLectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)). | Diagnostic test | – |
Primary outcome
Positivity of HPA-labelling
Time frame: between 2005 and 2018
Difference in HPA-binding among the phenotype of follicular lesions - percentage of positively labelled cancer cells: positive = ≥5% of cancer cells labelled positive
1 secondary outcome
HPA-binding and other tumor markers
Time frame: between 2005 and 2018
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 1 Oct 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.
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 Follicular Thyroid Cancer, 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 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 1 Oct 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?
Positivity of HPA-labelling (time frame: between 2005 and 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 1 Oct 2021.