Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04669951
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The patients will be drawn from the existing clinical biobank. The biobank is located at the department of pathology, Rigshospitalet. From this clinical biobank, a new temporary research biobank will be made. Supplementary sections from formalin-fixed paraffin embedded (FFPE) blocks containing tumor tissue will be cut and Haematoxylin and eosin (HE) and immunohistochemical (IHC) staining will be performed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'uPAR microexpression', 'timeFrame': 'Up to 6 months', 'description': 'Our primary objective is to investigate uPAR microexpression in gastroesophageal adenocarcinomas both qualitatively and semi-quantitatively. This will be done by a pathology analysis of gastroesophageal cancer resections.'}, {'measure': 'Tumor-to-background ratio', 'timeFrame': 'Up to 6 months', 'description': 'A pathology staining will determine the uPAR in the tumor compared with the healthy cells.'}], 'secondaryOutcomes': [{'measure': 'uPAR in patient groups', 'timeFrame': 'Up to 6 months', 'description': 'Baseline statistical analysis of patient groups and their expression of uPAR in their resected tumor tissues will be made.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urokinase plasminogen activator receptor', 'uPAR', 'Cardia', 'Adenocarcinoma', 'Immunohistochemistry'], 'conditions': ['Esophagus Cancer, Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate urokinase Plasminogen Activator Receptor (uPAR) microexpression in gastroesophageal cancer (adenocarcinomas) both qualitatively and semi-quantitatively and to evaluate if it offers a possibility for future imagining purposes.', 'detailedDescription': '* Sections of the tumor tissue will be HE stained.\n* Sections of the tumor tissue will be stained with an uPAR antibody for immunohistochemistry.\n* Immunohistochemical staining against cytokeratin which colors cancer cells will be made to assist the observer in the evaluation of uPAR microexpression pattern.\n* A semiqualitative scale corresponding to the level of uPAR expression will be made.\n* Quantitative polymerase chain reaction will be used to validate the immunohistochemistry uPAR expression pattern.\n* An electronic scoring system (digital pathology) will be trained to access the expression of uPAR in both tumor- and normal tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old.\n* Patients who underwent curatively intended surgery for gastroesophageal cancer\n* Patients who underwent surgery after 01-01-2016.\n\nExclusion Criteria:\n\n* Patients who applied for an exception from medical research at the "National Registry of Tissue Use."\n* Patients with other histological subtypes than adenocarcinoma.'}, 'identificationModule': {'nctId': 'NCT04669951', 'briefTitle': 'Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Urokinase-type Plasminogen Activator Receptor and Gastroesophageal Adenocarcinomas', 'orgStudyIdInfo': {'id': 'uPAR ECV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'uPAR expression', 'description': 'Immunohistochemistry', 'interventionNames': ['Other: uPAR immunohistochemistry']}], 'interventions': [{'name': 'uPAR immunohistochemistry', 'type': 'OTHER', 'description': 'Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression', 'armGroupLabels': ['uPAR expression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Michael Achiam, MD., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Department of Surgical Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Patrick Achiam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant, MD, DMSci, Ph.D., FEBS-OG, Ass. Professor', 'investigatorFullName': 'Michael Patrick Achiam', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}