Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04857203
Status:
UNKNOWN
Last Update Posted:
2022-08-08
First Post:
2021-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D030181', 'term': 'Vitamin D Response Element'}], 'ancestors': [{'id': 'D020218', 'term': 'Response Elements'}, {'id': 'D004742', 'term': 'Enhancer Elements, Genetic'}, {'id': 'D012045', 'term': 'Regulatory Sequences, Nucleic Acid'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D011401', 'term': 'Promoter Regions, Genetic'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D050436', 'term': 'Regulatory Elements, Transcriptional'}, {'id': 'D040461', 'term': 'Gene Components'}, {'id': 'D005796', 'term': 'Genes'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-05', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Role of Vitamin D in response to neoadjuvant therapy for the patients with locally advanced rectal cancer', 'timeFrame': '8 weeks', 'description': 'The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients with Rectal Cancer Vitamin D levels will be measured for all the patients just before the neoadjuvant therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer', 'neoadjuvant', 'vitamin D'], 'conditions': ['Rectal Cancer', 'Stage III Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'It has been reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. In addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. Therefore, the importance of predicting patients with pathological complete response has increased.\n\nIt has been reported that data obtained from PET-CT scans and clinical information such as tumor size, T stage, and N stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer.\n\nConsideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. Because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. There are a limited number of blood biomarkers such as CEA and IL-6 that have been studied in the literature.\n\nExperimental studies show that vitamin D suppresses inflammation and protects against cancer by triggering differentiation. In 1980, Cedric and Frank Garland stated for the first time that vitamin D may affect the survival of the patient after the diagnosis of colorectal cancer. In later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin D - 25 (OH) D and survival rates for colorectal cancer, breast and prostate cancer. In addition, 25 (OH) D serum concentration has been shown to be inversely related to colorectal cancer progression.\n\nIn the light of all these information, the role of serum vitamin D levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with locally advanced rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • All patients with locally advanced rectal cancer\n\nExclusion Criteria:\n\n* • below 18 years old\n\n * patients who did not received neoadjuvant therapy'}, 'identificationModule': {'nctId': 'NCT04857203', 'briefTitle': 'The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Training and Research Hospital'}, 'officialTitle': 'The Role of Vitamin D in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer', 'orgStudyIdInfo': {'id': '2767'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Low levels of Vitamin D', 'interventionNames': ['Diagnostic Test: Vitamin D']}, {'label': 'Group 2', 'description': 'High levels of Vitamin D', 'interventionNames': ['Diagnostic Test: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vitamin D levels will be measured for the patients undergoing neoadjuvant therapy in patients with locally advanced rectal cancer', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'state': 'None Selected', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Cihad Tatar, MD', 'role': 'CONTACT', 'email': 'tatarcihad@gmail.com', 'phone': '+905336599889'}, {'name': 'Mahmut E Cicek, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istanbul Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Cihad Tatar, MD', 'role': 'CONTACT', 'email': 'tatarcihad@gmail.com', 'phone': '+905336599889'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Cihad Tatar', 'investigatorAffiliation': 'Istanbul Training and Research Hospital'}}}}