Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT02342158
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2014-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists', 'timeFrame': '4-6 weeks after biopsy'}], 'secondaryOutcomes': [{'measure': 'Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing', 'timeFrame': '3.5 years'}, {'measure': 'Full exome and transcriptome sequencingof locally advanced and metastatic tumours', 'timeFrame': '6 years'}, {'measure': 'Circulating tumor DNA detection and characterization in locally advanced and metastatic disease', 'timeFrame': '4 years'}, {'measure': 'Circulating Tumor Cells (CTC) detection and characterization in breast cancer', 'timeFrame': '3.5 years', 'description': 'Comparison of three distinct methods for the CTC detection in blood'}, {'measure': 'Preclinical predictive clinical models validation (limited to breast cancer)', 'timeFrame': '4 years', 'description': 'Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasm Metastasis']}, 'referencesModule': {'references': [{'pmid': '35965534', 'type': 'DERIVED', 'citation': 'Sabatier R, Garnier S, Guille A, Carbuccia N, Pakradouni J, Adelaide J, Provansal M, Cappiello M, Rousseau F, Chaffanet M, Birnbaum D, Mamessier E, Goncalves A, Bertucci F. Whole-genome/exome analysis of circulating tumor DNA and comparison to tumor genomics from patients with heavily pre-treated ovarian cancer: subset analysis of the PERMED-01 trial. Front Oncol. 2022 Jul 29;12:946257. doi: 10.3389/fonc.2022.946257. eCollection 2022.'}, {'pmid': '34006291', 'type': 'DERIVED', 'citation': 'Bertucci F, Goncalves A, Guille A, Adelaide J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pecheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, Andre F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.'}]}, 'descriptionModule': {'briefSummary': 'PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years\n* Histological diagnosis of cancer\n* Locally advanced or metastatic, biopsiable disease\n* ECOG Performans Status ≤2\n* Affiliation to social security\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Emergency, Individually deprived of liberty or placed under the authority of a tutor\n* Patients with symptomatic or progressive brain metastasis\n* Patients who have only bone and/or brain metastases\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT02342158', 'acronym': 'PERMED01', 'briefTitle': 'Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003', 'orgStudyIdInfo': {'id': 'PERMED01-IPC 2014-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Locally advanced /metastatic cancer', 'interventionNames': ['Procedure: biopsy or surgical sampling', 'Other: blood sampling']}], 'interventions': [{'name': 'biopsy or surgical sampling', 'type': 'PROCEDURE', 'armGroupLabels': ['Locally advanced /metastatic cancer']}, {'name': 'blood sampling', 'type': 'OTHER', 'armGroupLabels': ['Locally advanced /metastatic cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research Center of Marseille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}