- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052359
Aberrant Helix Pomatia Agglutinin Binding Glycan Expression in Follicular Thyroid Tumours
September 25, 2021 updated by: Rajeev Parameswaran, National University Health System, Singapore
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
37
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore
- National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Positivity of HPA-labelling
Time Frame: between 2005 and 2018
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Difference in HPA-binding among the phenotype of follicular lesions - percentage of positively labelled cancer cells: positive = ≥5% of cancer cells labelled positive
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between 2005 and 2018
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HPA-binding and other tumor markers
Time Frame: between 2005 and 2018
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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)).
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between 2005 and 2018
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
August 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
September 11, 2021
First Posted (Actual)
September 22, 2021
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 25, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/00378
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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Memorial Sloan Kettering Cancer CenterCompletedThyroid Cancer, Papillary | Thyroid Cancer, Follicular | Thyroid Carcinoma | Thyroid Cancer | Thyroid Cancer (Follicular Cell) | BRAF V600E Mutation PositiveUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Thyroid Gland Medullary CarcinomaUnited States
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Bhavana KondaNational Comprehensive Cancer NetworkCompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Papillary Thyroid Cancer | Follicular Thyroid CancerUnited States
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