Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT05692895
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2023-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis and prognosis of colorectal carcinoma', 'timeFrame': 'Two or three days after staining tissue sections with PDL1 antibody', 'description': 'Immunohistochemical expression of PDL1 in primary colorectal carcinoma'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PDL1- Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer (CRC) is a highly heterogenous disease. It the third most commonly diagnosed cancer in the world and the second cause of death among cancer cases mortality. Its incidence is rising all over the world, especially in developing countries . In Egypt it is coming the seventh cancer in incidence according to World Health Organization (WHO, 2020). Although there is much improvement in the diagnosis and treatment, but CRC is still constituting a big impact on human life and health, so researchers are trying to find out new therapeutic targets .\n\nProgrammed cell death protein 1 (PD-1) is an inhibitory receptor which is expressed on the surface of T lymphocytes during activation. Its role is to control T cell effector activity for various cellular responses as infections, autoimmune reactions, and cancer .\n\nCancer cells develop PD-ligand1 (PD-L1) expression which is a transmembrane molecule belonging to B7 family. Its action is through PD-1/PD-L1 reaction, and causing invasion and metastasis of cancer cells by protecting it from immunosurveillance by inhibiting T cell effector function, leading to carcinogenesis and development of many cancers including colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective study will be carried out on 60 colorectal carcinoma specimens that were collected randomly from archives of Pathology Department, Faculty of Medicine, Sohag University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both endoscopic and excisional biopsy specimens.\n2. All the studied cases include sufficient materials for the immunohistochemical study.\n3. Complete clinical data\n\nExclusion Criteria:\n\n1. Patients with recurrence of the primary tumor.\n2. Patients with a history of preoperative chemotherapy and/or radiotherapy.\n3. Insufficient or tiny tissue biopsies'}, 'identificationModule': {'nctId': 'NCT05692895', 'briefTitle': 'PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Immunohistochemical Expression of PDL1 In Primary Colorectal Carcinoma and Its Prognostic Impact', 'orgStudyIdInfo': {'id': 'Soh-Med-22-12-36'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amira A Abdelnaby, Lecturer', 'role': 'CONTACT', 'email': 'ameraabdelnaby55@gmail.com', 'phone': '01002097612'}, {'name': 'Amira Ahmed Abdelnaby, Lecturer', 'role': 'CONTACT', 'email': 'ameraabdelnaby55@gmail.com', 'phone': '01002097612'}], 'overallOfficials': [{'name': 'Amira A Abdelnaby, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine ,Sohag university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of pathology', 'investigatorFullName': 'Amira Ahmed Abdelnaby', 'investigatorAffiliation': 'Sohag University'}}}}