Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-02 @ 9:51 AM
Study NCT ID:
NCT05052359
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aberrant Helix Pomatia Agglutinin Binding Glycan Expression in Follicular Thyroid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018263', 'term': 'Adenocarcinoma, Follicular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-25', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-11', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positivity of HPA-labelling', 'timeFrame': 'between 2005 and 2018', 'description': 'Difference in HPA-binding among the phenotype of follicular lesions - percentage of positively labelled cancer cells: positive = ≥5% of cancer cells labelled positive'}], 'secondaryOutcomes': [{'measure': 'HPA-binding and other tumor markers', 'timeFrame': 'between 2005 and 2018', 'description': '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)).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycosylation'], 'conditions': ['Follicular Thyroid Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05052359', 'briefTitle': 'Aberrant Helix Pomatia Agglutinin Binding Glycan Expression in Follicular Thyroid Tumours', 'organization': {'class': 'OTHER', 'fullName': 'National University Health System, Singapore'}, 'officialTitle': 'Aberrant Helix Pomatia Agglutinin Binding Glycan Expression Changes With the Phenotype of Follicular Thyroid Tumours', 'orgStudyIdInfo': {'id': '2014/00378'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lectin-histochemistry retrospectively performed', 'type': 'DIAGNOSTIC_TEST', '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)).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Health System, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. Rajeev Parameswaran FRCSI MPhil FRCS FAMS', 'investigatorFullName': 'Rajeev Parameswaran', 'investigatorAffiliation': 'National University Health System, Singapore'}}}}