Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:43 PM
Study NCT ID:
NCT04628806
Status:
UNKNOWN
Last Update Posted:
2021-05-14
First Post:
2020-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'circulating tumor cells and biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic response to initial treatment', 'timeFrame': '3 months after study enrollment', 'description': 'radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC'}], 'secondaryOutcomes': [{'measure': 'Correlation between number of CTC isolated with HSP70 compared to EpCAM', 'timeFrame': '3 months (at both CTC assessment timepoints)', 'description': 'the number of CTCs obtained by the novel HSP70 method will be compared to the current gold standard that uses EpCAM. This will be performed for the whole cohort and separate for each tumor site'}, {'measure': 'Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs', 'timeFrame': '3 months (at both CTC assessment timepoints)', 'description': 'computed tomography parameters of primary tumors and metastases will be analysed and parameters extraced that are differentially expressed between both. The same will be performed for genomic mutations and gene expression of the primary tumor and CTC. Correlation analyses will be performed to analyze if radiographic parameters resemble genetic alterations'}, {'measure': 'Progression free survival', 'timeFrame': '2 years', 'description': 'Progression free survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site'}, {'measure': 'Overall survival', 'timeFrame': '2 years', 'description': 'Overall survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma Stage IV', 'Sarcoma', 'Squamous Cell Carcinoma', 'Pancreatic Cancer Stage IV', 'Prostate Cancer', 'Breast Cancer Stage IV']}, 'referencesModule': {'references': [{'pmid': '40313865', 'type': 'DERIVED', 'citation': 'Roy AA, Pandey A, Dhas N, Hegde MM, Parekh HS, Andugulapati SB, Nandakumar K, Satish Rao BS, Mutalik S. The Confluence of Nanotechnology and Heat Shock Protein 70 in Pioneering Glioblastoma Multiforme Therapy: Forging Pathways Towards Precision Targeting and Transformation. Adv Pharmacol Pharm Sci. 2025 Apr 24;2025:1847197. doi: 10.1155/adpp/1847197. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors.\n\nCTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM.\n\nAdditionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'oncological patients treated at a tertiary center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic malignant melanoma (stage IV)\n* Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)\n* Metastatic breast cancer\n* Metastatic sarcoma\n* Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis\n* hormone-refractory prostate cancer\n\nExclusion Criteria:\n\n* psychiatric disorders that impede adequate informed consent'}, 'identificationModule': {'nctId': 'NCT04628806', 'acronym': 'HSP70CTC', 'briefTitle': 'Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.', 'orgStudyIdInfo': {'id': 'HSP70CTC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HSP70CTC', 'description': 'Isolation of circulating tumor cells by HSP70', 'interventionNames': ['Diagnostic Test: CTC isolation by HSP70']}], 'interventions': [{'name': 'CTC isolation by HSP70', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.', 'armGroupLabels': ['HSP70CTC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Zschaeck, M.D.', 'role': 'CONTACT'}], 'facility': 'Klinik für Radioonkologie und Strahlentherapie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Sebastian Zschaeck, MD', 'role': 'CONTACT', 'email': 'sebastian.zschaeck@charite.de', 'phone': '+4930450650764'}], 'overallOfficials': [{'name': 'Sebastian Zschaeck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité'}]}, 'ipdSharingStatementModule': {'url': 'https://www.cancerimagingarchive.net/', 'timeFrame': 'data will be uploaded 2 years after study completion', 'ipdSharing': 'YES', 'description': 'patients can sign an optional agreement that their pseudonymized imaging and genetic data will be shared on cancerimagingarchive.net', 'accessCriteria': 'no specific criteria except proper referencing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Sebastian Zschaeck, principal investigator', 'investigatorFullName': 'Sebastian Zschaeck', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}