Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-29 @ 8:04 PM
Study NCT ID:
NCT02049658
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2014-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2014-01-26', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the substances used for identifying tumors by the sniff dogs', 'timeFrame': '12 months', 'description': 'GCMS etc will be used to compare the volatile compounds between the sera from cancers patients and the from non-cancer subjects, the suspected VOCs will be tested by the dog for conformation.'}], 'primaryOutcomes': [{'measure': 'sensitivity and specificity of the sniff dogs as a tool in diagnosing tumors', 'timeFrame': '12 months', 'description': 'The results that obtained from the dogs will be compared with these of the pathological examinations. Sensitivity = the No. of patients identified by the dogs as cancers / the No. of patients suffering from cancer confirmed by pathological examination. Specificity = No. of subjects signaled by the dog as non-cancers / No. of subjects confirmed by pathological examination as non-cancer subjects.'}], 'secondaryOutcomes': [{'measure': 'behavior patterns of the sniff dogs to different diseases', 'timeFrame': '12 months', 'description': 'The behavior (lying before the tank for positive, neglecting the tanks) of the dog will be recorded and compared with the results of the pathological examination.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tumor', 'cancer'], 'conditions': ['Neoplasia']}, 'descriptionModule': {'briefSummary': 'Previous studies have demonstrated that sniff dogs can identify cancer patients from healthy subjects through sniffing exhaled breath air or blood or serum or urine or feces. It is hypothesized that sniff dogs may be used as a tool in identifying cancer patients in the high risk population or suspected patients. Trained dogs will sniff serum from participants who are suspected to suffer from tumor by their physicians and not yet but will be diagnosed by pathological examination.The results will be compared with the outcome of the pathological examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Healthy volunteers who have been examined by the currently used procedures and find to be without tumors.\n* Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers who have been examined by the currently used procedures and find to be without tumors.\n* Patients in the breast surgery, thoracic surgery, gynecological and neurosurgery departments with lesions with characteristics of tumors\n\nExclusion Criteria:\n\n* Patients who have had pathological results'}, 'identificationModule': {'nctId': 'NCT02049658', 'briefTitle': 'The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'The Sensitivity and Specificity of Sniff Dog as a Tool in Diagnosing the Suspected Tumor Patients', 'orgStudyIdInfo': {'id': 'Xiang-Ya 0003'}, 'secondaryIdInfos': [{'id': 'XY 0003'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers', 'description': 'Healthy volunteers measured by currently used healthy screening procedures'}, {'label': 'Suspected breast cancer subjects', 'description': 'Suspected breast cancer subjects without pathological examination yet but will have it soon'}, {'label': 'Suspected lung cancer subjects', 'description': 'Suspected lung cancer subjects without pathological examination yet but will have it soon'}, {'label': 'Suspected neurological tumor subjects', 'description': 'Suspected neurological tumor subjects without pathological examination yet but will have it soon'}, {'label': 'Suspected patients with gynecological tumor', 'description': 'Suspected subjects with gynecological tumors without pathological examination yet but will have it soon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang-Qing Gao, MD PhD', 'role': 'CONTACT', 'email': 'cgao851@126.com', 'phone': '86 188 7486 9488'}, {'name': 'Ya-Qin Wang, MD PhD', 'role': 'CONTACT', 'email': 'wdove.bb@163.com', 'phone': '152 7481 0930'}, {'name': 'Chang-Qing Gao, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Scientific Research with Animal Models, CSU', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Chang-Qing Gao, MD PhD', 'role': 'CONTACT', 'email': 'cgao851@126.com', 'phone': '86 188 7486 9488'}, {'name': 'Ya-Qin Wang, MD PhD', 'role': 'CONTACT', 'email': 'wdove.bb@163.com', 'phone': '86 15274810930'}], 'overallOfficials': [{'name': 'Chang-Qing Gao, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang-Qing Gao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Chang-Qing Gao', 'investigatorAffiliation': 'Central South University'}}}}