Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02979795
Status:
UNKNOWN
Last Update Posted:
2016-12-02
First Post:
2016-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor regression rate', 'timeFrame': 'within 8 weeks after completion of chemoradiotherapy', 'description': 'complete tumor regression rate(TRG) with tumor regression graded at at surgical resection at 8 weeks after completion of chemoradiotherapy'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '5 year'}, {'measure': 'Overall survival', 'timeFrame': '5 year'}, {'measure': 'Local recurrence', 'timeFrame': '5 year'}, {'measure': 'Distant metastasis', 'timeFrame': '5 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rectal Cancer', 'Chemoradiation']}, 'descriptionModule': {'briefSummary': 'Rectal cancer, comprised of 30% of overall colorectal cancer cohort, is one of the leading cancers of Taiwan. In patients with advanced disease, the standard of care is concurrent chemoradiotherapy (CCRT) before surgery. After CCRT, the abscopal effect, a phenomenon that localized radiation not only destroys local tumor but also inhibits the growth of tumor at the remote site, has been observed. This effect is believed to be associated with tumor immune response. In addition, other immune checkpoint molecules, such as Programmed cell death-1(PD-1), Programmed cell death ligand-1 (PD-L1), and Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), have been reported associated with therapeutic outcome. However, after CCRT, more than 50% of patients were still either having persistent disease or developed distant metastasis. To improve therapeutic outcome of patients with rectal cancer, this project, thus, aims at exploring the evolution of factors that may affect the abscopal effect and immune checkpoint functions in tissues and in blood before and after CCRT.', 'detailedDescription': 'For most patients, preoperative chemoradiotherapy results in clinically tumor regression, but the degree of response varies among patients. There are approximately 40-60% of LARC patients treated with CCRT achieve some degree of pathologic response. However, there is yet an effective method before the commencement of CCRT that can predict how patients will respond to CCRT and can subsequently render better survival. Identify patents who will benefit most from CCRT is crucial not only in lowering treatment-related morbidity and sustaining local control but also to improve survival rate in LARC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rectal cancer patients in China Medical University Hospital (Age: 20 yrs and older)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal cancer patients in China Medical University Hospital (Age limit: 20 yrs and older)\n\nExclusion Criteria:\n\n* Pregnancy, Disabilities'}, 'identificationModule': {'nctId': 'NCT02979795', 'briefTitle': 'Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis', 'orgStudyIdInfo': {'id': 'CMUH105-REC2-072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Preoperative chemoradiotherapy', 'type': 'PROCEDURE', 'description': 'Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Huang Chih-Yang, Ph.D', 'role': 'CONTACT', 'email': 'T96752@mail.cmuh.org.tw', 'phone': '886422052121', 'phoneExt': '3677'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Kan Sun Clifford Chao, MD', 'role': 'CONTACT', 'email': 'D94032@mail.cmuh.org.tw', 'phone': '886422052121', 'phoneExt': '2976'}], 'overallOfficials': [{'name': 'Kan Sun Clifford Chao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cancer center', 'investigatorFullName': 'Kun-San Clifford Chao', 'investigatorAffiliation': 'China Medical University Hospital'}}}}