Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT01292369
Status:
UNKNOWN
Last Update Posted:
2011-08-18
First Post:
2011-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System 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_WITHOUT_DNA', 'description': 'Breath samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-17', 'studyFirstSubmitDate': '2011-02-06', 'studyFirstSubmitQcDate': '2011-02-08', 'lastUpdatePostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System performance', 'timeFrame': '10 months', 'description': 'Sensitivity and specificity of NaNose system in diagnosing cancer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breath test', 'colon cancer', 'breast cancer'], 'conditions': ['Breast Cancer', 'Colon Cancer']}, 'descriptionModule': {'briefSummary': "The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.", 'detailedDescription': 'Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.\n\nIn the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.\n\nThe current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.\n\nMen and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.\n\nThe research goal is to test the NaNose system ability to discriminate between healthy and sick.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women coming for medical tests:\n\n1. Women coming for a breast biopsy following a suspicious breast imaging result.\n2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women attending Rambam medical center for either breast biopsy or colonoscopy.\n* Suspicious finding on breast imaging requiring a biopsy.\n* Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.\n\nExclusion Criteria:\n\n* Other known active malignancy.\n* History of malignant disease and treatments.'}, 'identificationModule': {'nctId': 'NCT01292369', 'briefTitle': 'Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study', 'orgStudyIdInfo': {'id': 'RMB-0566.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer', 'description': 'Women diagnosed with breast cancer by a positive biopsy test after mammography.'}, {'label': 'Breast control', 'description': 'Women with negative biopsy result done due to a suspicious mammography exam.'}, {'label': 'Colon cancer', 'description': 'Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy.'}, {'label': 'Colon control', 'description': 'Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Zahava Galimidi, Dr.', 'role': 'CONTACT', 'email': 'z_gallimidi@rambam.health.gov.il', 'phone': '972-4-8543684'}, {'name': 'Zahava Galimidi, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yehuda Hovers, Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'RAMBAM medical center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'status': 'NOT_YET_RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ori Segol, MD', 'role': 'CONTACT', 'email': 'ori_segol@clalit.org.il', 'phone': '04-8250356'}, {'name': 'Ori Segol, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carmel medical center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Zahava Galimidi, Dr.', 'role': 'CONTACT', 'email': 'z_gallimidi@rambam.health.gov.il', 'phone': '972-4-8543684'}, {'name': 'Yehuda Hovers, Prof.', 'role': 'CONTACT', 'email': 'y_chowers@rambam.health.gov.il', 'phone': '972-4-8543608'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'NaNose LTD', 'oldOrganization': 'AMIT- Alfred Mann institute in the technion'}}}}