Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
Study NCT ID:
NCT02066259
Status:
UNKNOWN
Last Update Posted:
2014-08-05
First Post:
2014-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic 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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Human plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1080}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2014-02-09', 'studyFirstSubmitQcDate': '2014-02-17', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants in each of the clinicaly defined groups (0,1 and 2).', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colon cancer', 'cancer associated auto antibodies', 'colon cancer blood test'], 'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '24324350', 'type': 'BACKGROUND', 'citation': 'Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population', 'detailedDescription': 'The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -\n\n1. Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.\n2. Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population.\n\nThe study will be considered successful it can achieve at least one of the following sets of performances -\n\n1. For the OctavaGold - 95% specificity with at least 50% sensitivity.\n2. For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'There are 3 different populations that will participate in the study-\n\n1. Any person with suspected colon abnormality, that will be classified after colonoscopy/surgery as "colon cancer patient" will be a part of group1 - "Patient".\n2. Any person with suspected colon abnormality, that will be classified after colonoscopy as "benign polyp" will be a part of group2 - "benign".\n3. Any person with suspected colon abnormality, that will be classified after colonoscopy as "normal/healthy" will be a part of group0 - "healthy".', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects 18 years or over. Subjects scheduled for colonoscopy or surgery\n\nExclusion Criteria:\n\n* Subjects less than 18 years of age\n* Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma\n* Autoimmune disorders diagnosed subjects\n* Hematological malignancies\n* Subjects under active chemotherapy treatment or chemotherapy in the past 6 months\n* Steroid treatment in the past 3 months\n* Subject undergoing immunosuppressive treatments\n* Subject with verified melanoma colon cancer\n* Subject with verified sarcoma colon cancer'}, 'identificationModule': {'nctId': 'NCT02066259', 'briefTitle': 'OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eventus Diagnostics Ltd'}, 'officialTitle': 'OctavaColon Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol', 'orgStudyIdInfo': {'id': 'OctavaColon_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy_0', 'description': 'healthy, people with normal (negative) colonoscopy results.'}, {'label': 'patient_1', 'description': 'people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ'}, {'label': 'benign_2', 'description': 'people with biopsy verified benign polyps of the colon one of the following - Villus adenoma, Tubular adenoma, Low grade dysplasia, Intermediate grade dysplasia, High grade dysplasia, Severe dysplasia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85025', 'city': 'Beersheba', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gilbert Sabag, MD', 'role': 'CONTACT', 'email': 'GilbertS@clalit.org.il'}, {'name': 'Gilbert Sabag, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '34362', 'city': 'Haifa', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arie Bitterman, MD', 'role': 'CONTACT', 'email': 'bitterman@clalit.org.il'}, {'name': 'Arie Bitterman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lilly Merdler, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dabbah Kamal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': '"Carmel" Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Adi Lahat, MD', 'role': 'CONTACT', 'email': 'Adi.Lahat@sheba.health.gov.il'}, {'name': 'Adi Lahat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Tel hashomer', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Galit Yahalom, Ph.D', 'role': 'CONTACT', 'email': 'galit@eventusdx.com', 'phone': '+972546922422'}], 'overallOfficials': [{'name': 'Galit Yahalom, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eventus Dx'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eventus Diagnostics Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}