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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05052359
Other study ID # 2014/00378
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date September 1, 2021

Study information

Verified date September 2021
Source National University Health System, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date September 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
Lectin-histochemistry retrospectively performed
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)).

Locations

Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 between 2005 and 2018
Secondary 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)). between 2005 and 2018
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