Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-02-23 @ 6:26 AM
Study NCT ID:
NCT03151759
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients
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': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2007-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2017-05-10', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Matrilysin levels', 'timeFrame': '1 - 6 weeks', 'description': 'Inflammatory markers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rectal cancer patients undergoing surgery with or without neoadjuvant radiotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdenocarcinoma of the rectum, ability to understand written and oral information, written consent.\n\nExclusion Criteria:\n\nColon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.'}, 'identificationModule': {'nctId': 'NCT03151759', 'acronym': 'MMP-7', 'briefTitle': 'MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Effect of Long and Short Radiotherapy on MMP-7 Levels in Rectal Cancer Treatment', 'orgStudyIdInfo': {'id': 'LU155-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No radiotherapy', 'description': 'Surgery only'}, {'label': '25 Gray radiotherapy', 'description': 'Surgery after short term radiotherapy', 'interventionNames': ['Radiation: Neoadjuvant radiotherapy']}, {'label': '50 Gray radiotherapy', 'description': 'Surgery after long term radiotherapy', 'interventionNames': ['Radiation: Neoadjuvant radiotherapy']}], 'interventions': [{'name': 'Neoadjuvant radiotherapy', 'type': 'RADIATION', 'description': 'Neoadjuvant radiotherapy prior to rectal cancer surgery', 'armGroupLabels': ['25 Gray radiotherapy', '50 Gray radiotherapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}