Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 11:54 AM
Study NCT ID:
NCT01628328
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colonic Stent and Tumor Cell Dissemination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of circulating tumor cell level before and after colonic stenting for patients with obstructive colorectal cancer', 'timeFrame': 'Before and first 3 days after procedure', 'description': "The patients' peripheral blood will be collected before and on first 3 days after the procedure."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonic stenting', 'colorectal cancer obstruction', 'circulating tumor cell'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the hypothesis of tumor cell dissemination after colonic stenting for obstructing colorectal cancer by measuring the level of plasma circulating tumor cell before and after the procedure of successful colonic stenting in patients.', 'detailedDescription': '1. Patient recruitment:\n\n Patients will be recruited from the Division of Colorectal Surgery, Department of Surgery, the University of Hong Kong, over a 12 - 18 months period. Our institution is a tertiary referral center for colorectal cancer patients in Hong Kong. Informed consent will be obtained from the patients after the inclusion criteria are met.\n\n The study plans to recruit 25 patients in the colonic stenting group to compare with 15 patients in the control group.\n\n Inclusion criteria:\n\n Colonic stenting group\n 1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment\n 2. Age \\> 18 years and is able to give informed consent\n 3. Informed consent for blood collection obtained\n\n Control group\n 1. Patients with colorectal cancer who have colonoscopy without stenting\n 2. Age \\> 18 years and is able to give informed consent\n 3. Informed consent for blood collection obtained\n2. Blood collection and examination for circulating tumor cell\n\nAbout 10ml of EDTA blood will be collected for examination before the procedure (colonoscopic stenting or colonoscopy in the control group) and blood collection daily will be repeated for 3 days after procedure. Blood will be sent to the laboratory for processing within 2 hours of withdrawal. Circulating tumour cells, which are characterized by CD45- (to exclude hematopoietic cells), CD326+ (to mark epithelial cells), CK18+ and CK19+ (to mark intestinal cells), i.e. cells expressing CD45-CD326+CK18/19+, will be detected by fluorescence activated cell sorting (FACS).\n\nFor each ml of blood, 1 ml of FCM Lysing solution will be added and allowed to incubate for 5 minutes to lyse the red blood cells, followed by centrifugation at 1000 RPM for 5 minutes. Supernatant will then be aspirated, and the pellet resuspend in approximately 1 ml cold 1X PBS. 10 µl of the appropriate antibody will be added into the tubes, vortexed and incubated for 15 in dark and room temperature. After incubation, cells will be washed with PBS and then incubated with the second antibody. The process is repeated until all 4 antibodies have been labelled to the cells. Cells will then be analysed on a FACS machine (MoFlo, Beckman Coulter).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study plan to recruit 20-30 patients in the stenting group and about 10-20 patients in the control groups.\n\nThere is no previous study on this topic and hence, no information availabe for statistical analysis of sample size required to show a difference.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colonic stenting group\n\n 1. Patients with obstructive colorectal cancer that requires colonic stenting as treatment\n 2. Age \\> 18 years and is able to give informed consent\n 3. Informed consent for blood collection obtained\n\nControl group\n\n1. Patients with colorectal cancer who have colonoscopy without stenting\n2. Age \\> 18 years and is able to give informed consent\n3. Informed consent for blood collection obtained\n\nExclusion Criteria:\n\n* Patients who refuse or who is unable to give informed consent on blood taking for the study.'}, 'identificationModule': {'nctId': 'NCT01628328', 'briefTitle': 'Colonic Stent and Tumor Cell Dissemination', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Impact of Metallic Stent Insertion for Obstructing Colorectal Cancer on Circulating Tumor Cell Dissemination', 'orgStudyIdInfo': {'id': 'colonstent'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stenting', 'description': 'patient who received colonic stenting for obstructive colorectal cancer'}, {'label': 'Control', 'description': 'patients who had only colonoscopy without obstruction and without stenting'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jensen TC Poon, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}