Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-19 @ 2:23 AM
Study NCT ID:
NCT02824835
Status:
UNKNOWN
Last Update Posted:
2016-07-07
First Post:
2016-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strigolactones and Dysplastic Colonic Lesions or Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}], '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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-02', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-07-02', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of cells with reduced viability after dose-dependent exposure', 'timeFrame': '24 hours of exposure to strigolactone'}, {'measure': 'percentage of cells in G2/M arrest after dose-dependent exposure', 'timeFrame': '24 hours of exposure to strigolactone', 'description': 'analysis of cell cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonic Neoplasms', 'Colonic Polyps']}, 'referencesModule': {'references': [{'pmid': '26192476', 'type': 'BACKGROUND', 'citation': 'Mayzlish-Gati E, Laufer D, Grivas CF, Shaknof J, Sananes A, Bier A, Ben-Harosh S, Belausov E, Johnson MD, Artuso E, Levi O, Genin O, Prandi C, Khalaila I, Pines M, Yarden RI, Kapulnik Y, Koltai H. Strigolactone analogs act as new anti-cancer agents in inhibition of breast cancer in xenograft model. Cancer Biol Ther. 2015;16(11):1682-8. doi: 10.1080/15384047.2015.1070982. Epub 2015 Jul 20.'}, {'pmid': '22476848', 'type': 'BACKGROUND', 'citation': 'Pollock CB, Koltai H, Kapulnik Y, Prandi C, Yarden RI. Strigolactones: a novel class of phytohormones that inhibit the growth and survival of breast cancer cells and breast cancer stem-like enriched mammosphere cells. Breast Cancer Res Treat. 2012 Aug;134(3):1041-55. doi: 10.1007/s10549-012-1992-x. Epub 2012 Mar 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of the plant hormones strigolactones, on cell cultures of colonic polyps and colorectal cancer.', 'detailedDescription': 'Strigolactones have been shown to anti-proliferative and pro-apoptotic effects in cell cultures of breast and prostate origin, partially by down-regulation of cyclin B1 and induction of cell cycle arrest. In this study the investigators intend to take biopsies from benign colonic polyps and cancer tissue, culture intestinal explants and generate immortalized primary cells as a platform to assess the effect of this plant hormone on cell viability, cell mobility, apoptosis and cytoskeleton modifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing colonoscopy who have positive findings (polyps, cancer) during the procedure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with positive findings during colonoscopy\n\nExclusion Criteria:\n\n* Patients below 18 years old\n* Patients who cannot sign a consent form'}, 'identificationModule': {'nctId': 'NCT02824835', 'briefTitle': 'Strigolactones and Dysplastic Colonic Lesions or Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'The Effect of the Plant Hormones Strigolactones on Cultures of Dysplastic Colonic Lesions and Cancer', 'orgStudyIdInfo': {'id': 'IDO123'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adenoma group', 'description': 'Patients with adenoma. Biopsies are taken before endoscopic resection.', 'interventionNames': ['Procedure: biopsy during colonoscopy']}, {'label': 'cancer group', 'description': 'Patients with colorectal cancer. Biopsies are taken before surgical resection.', 'interventionNames': ['Procedure: biopsy during colonoscopy']}], 'interventions': [{'name': 'biopsy during colonoscopy', 'type': 'PROCEDURE', 'description': 'sampling the lesion with forcept biopter', 'armGroupLabels': ['adenoma group', 'cancer group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ido Laish, MD', 'role': 'CONTACT', 'email': 'ido.lish@clalit.org.il', 'phone': '+ 972-9-7473261'}], 'overallOfficials': [{'name': 'Ido Laish, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'ido laish', 'investigatorAffiliation': 'Meir Medical Center'}}}}