Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT03703557
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Interventional, prospective, open, monocentric study with risks and minimal constraints'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ascertain breast cancer olfactive signature (Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®)', 'timeFrame': '12 months', 'description': 'Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®) on hands. Friction of the hands according to the protocol before and after surgical excision of the tumor. Sorbstar® analyses will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.'}], 'secondaryOutcomes': [{'measure': 'Ascertain breast cancer olfactive signature from the tumor (Isolation of volatile Organic Compounds to tumor breast samples by a sensitive technique with an odor-sensing polymer (Sorbstar®).', 'timeFrame': '13 months', 'description': 'During the surgical procedure an odor-sensing polymer (Sorbstar®) over the tumor is placed. Sorbstar® analyzes will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.'}, {'measure': 'Ascertain breast cancer detection by the dogs of Curie Institut', 'timeFrame': '13 months', 'description': 'Patients sleep over a night with a compress positioned on the affected breast before and after surgery. The compress will be analyzed by the dogs of Curie Institut (results cancer/not cancer).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast', 'Volatile organic compounds'], 'conditions': ['Breast Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'To ascertain the possibilities to isolate the breast cancer olfactive signature.', 'detailedDescription': 'Patient recruitment during the first surgery consultation in Curie Institute. Odor sampling (non-invasive) with an odor-sensing polymer (Sorbstar® polymer developed especially for the trace level analysis), on:\n\n* The hands, before and after surgical excision of the tumor (friction of the hands)\n* The diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night)\n* The tumor, during the surgical procedure (odor collection over a tumor sample).\n\nEach patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. The samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection\n2. Of-Age female patient (over 18 years old)\n3. Life expectancy \\> to 1 year at the inclusion\n4. Performance status: 0 or 1 or 2\n5. Patient benefiting from the social security\n6. Signature informed consent of the study\n\nExclusion Criteria:\n\n1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated.\n2. Wound presence on breasts\n3. Male subjects\n4. Specified metastatic breast cancer\n5. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)\n6. Persons under guardianship or deprived of liberty\n7. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT03703557', 'acronym': 'KDOG2', 'briefTitle': 'Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer', 'orgStudyIdInfo': {'id': 'IC 2018-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorbstar®', 'description': 'Odour sampling: Rub hands with Sorbstar® before and post-surgery', 'interventionNames': ['Diagnostic Test: Sorbstar®']}, {'type': 'EXPERIMENTAL', 'label': 'Dog detection', 'description': 'Odour sampling: Sleep over a night with a compress on the affected breast before and after surgery', 'interventionNames': ['Diagnostic Test: Odour sampling']}], 'interventions': [{'name': 'Sorbstar®', 'type': 'DIAGNOSTIC_TEST', 'description': 'Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.', 'armGroupLabels': ['Sorbstar®']}, {'name': 'Odour sampling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Analyzed by the dogs of Curie Institute at the training centers', 'armGroupLabels': ['Dog detection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'INSTITUT CURIE - Site de Saint Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}], 'overallOfficials': [{'name': 'Roman ROUZIER, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Curie'}, {'name': 'Isabelle FROMANTIN, Phd, IDE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Curie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}