Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-03-04 @ 2:58 PM
Study NCT ID:
NCT06807502
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional study with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device.\n\nA case-control study with longitudinal, prospective, single-center follow-up.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the kinetics of CTC during treatment', 'timeFrame': 'From enrollement to the end of follow up at 9 months', 'description': 'Evolution of the number of CTC isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients. Average number of CTCs measured during the study (D0, W6, W12, W24, W36)'}], 'secondaryOutcomes': [{'measure': 'Molecular characterisation of CTC', 'timeFrame': 'From enrollement to the end of follow up at 9 months', 'description': 'Analysis of the expression of specific antigens and the presence of informative mutations on CTCs isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients during the study (D0, W6, W12, W24, W36)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTC', 'Circulating Tumor Cells', 'Detection', 'Breast Cancer', 'Follow-up', 'Liquid Biopsy', 'Blood Test'], 'conditions': ['Breast Cancer, Metastatic', 'Breast Cancer Invasive', 'Breast Cancer Early Stage Breast Cancer (Stage 1-3)']}, 'descriptionModule': {'briefSummary': 'Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.\n\nThe identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only individuals who self-identify as female are eligible to participate to evaluate breast cancer within a homogenized cohort, ensuring more relevant and reliable biostatistical analyses', 'healthyVolunteers': True, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nFor all participants :\n\n* Age greater than or equal to 18 years\n\nFor participants with metastatic breast cancer:\n\n\\- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.\n\nFor participants with non-metastatic invasive breast cancer:\n\n\\- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)\n\nFor healthy volunteers:\n\n* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest one year before inclusion\n* Participant with no history of cancer\n\nEXCLUSION CRITERIA\n\nFor all participants:\n\n* Age less than 18 years old\n* Refusal to participate or withdrawal of consent\n* Pregnant and/or breastfeeding women\n* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.\n\nFor participants with breast cancer:\n\n\\- Absence of CTC during screening\n\nFor healthy volunteers:\n\n* History of cancer\n* Detection of CTC (positive profile) during screening'}, 'identificationModule': {'nctId': 'NCT06807502', 'acronym': 'PROBE-CTC', 'briefTitle': 'Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'ScreenCell'}, 'officialTitle': 'Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device', 'orgStudyIdInfo': {'id': '2024-A01101-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Donor', 'description': 'Participants with no history of cancer and free from any cancer at the time of inclusion', 'interventionNames': ['Device: The DM/DIV ScreenCell is the experimental product studied during this research']}, {'type': 'EXPERIMENTAL', 'label': 'Metastatic', 'description': 'Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion', 'interventionNames': ['Device: The DM/DIV ScreenCell is the experimental product studied during this research']}, {'type': 'EXPERIMENTAL', 'label': 'No metastatic', 'description': 'Participants with invasive breast cancer but non-metastatic', 'interventionNames': ['Device: The DM/DIV ScreenCell is the experimental product studied during this research']}], 'interventions': [{'name': 'The DM/DIV ScreenCell is the experimental product studied during this research', 'type': 'DEVICE', 'description': 'The product is not used directly on the subject, but on a blood sample taken from the participant.', 'armGroupLabels': ['Healthy Donor', 'Metastatic', 'No metastatic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Michel VANNETZEL, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CMC Ambroise Paré Hartmann', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}], 'centralContacts': [{'name': 'Jessica GROULT, Ph.D', 'role': 'CONTACT', 'email': 'jgroult@screencell.com', 'phone': '0033669645318'}, {'name': 'Sina NASERIAN, Ph.D', 'role': 'CONTACT', 'email': 'snaserian@screencell.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ScreenCell', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AXELYS SANTE', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}