Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-25 @ 7:40 PM
Study NCT ID:
NCT04104633
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2019-09-24', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of molecular karyotype performed from liquid biopsy: copies number variations (CNV)', 'timeFrame': 'Up to surgery', 'description': 'Feasibility of molecular karyotype showing acquired copies number variations (CNV) on whole genome performed from ctDNA isolated from blood sample in patients with breast or colorectal cancer'}], 'secondaryOutcomes': [{'measure': "Identification of patient's tumor genomic profile with blood sample", 'timeFrame': 'Up to surgery', 'description': "Identification of patient's tumor genomic profile by comparison between genomic profile of primitive tumor obtained by CGH array and genomic profile of ctDNA obtained by Massive Parallel Sequencing"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ctDNA', 'Molecular karyotype'], 'conditions': ['Breast Cancer', 'Colo-rectal Cancer']}, 'descriptionModule': {'briefSummary': "There are several types of circulating DNA: DNA from patient's existing cells, foetal DNA in the case of pregnant woman, and tumoral DNA in the case of patients with cancer. These circulating tumoral DNA (ctDNA) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the Massive Parallel Sequencing technique (MPS).\n\nThis study focus on using this technique on breast and colorectal cancers in which no analysis of CNV (tumor origin marker) with this technique has been performed yet. It is a prospective, pilot, monocentric, feasibility study on genomic profile. The study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctDNA with the MPS approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by CGH array (Comparative Genomic Hybridization) from primitive tumor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Signed consent\n* Women with invasive breast carcinoma, NOS, with a radiologically measurable tumor of more than 10 mm (stade I to III)\n* Patients with invasive colorectal adenocarcinoma with a radiologically measurable tumor of more than 10 mm (stade I to III)\n* Patients who primary surgery is planned\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy or neoadjuvant radiotherapy\n* Other cancer\n* BMI \\> 30\n* Pregnant woman\n* Patients under protective administration or deprived of liberty'}, 'identificationModule': {'nctId': 'NCT04104633', 'briefTitle': 'Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Henri Duffaut - Avignon'}, 'officialTitle': 'Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA', 'orgStudyIdInfo': {'id': 'DEGENCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with breast or colorectal cancer', 'description': '10 patients with invasive breast carcinoma, not otherwise specified (NOS) (Stade I to III) and 10 patients with invasive colorectal adenocarcinoma (Stade I to III)', 'interventionNames': ['Procedure: Blood samples']}], 'interventions': [{'name': 'Blood samples', 'type': 'PROCEDURE', 'description': '30 ml of blood collection', 'armGroupLabels': ['Patients with breast or colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84000', 'city': 'Avignon', 'country': 'France', 'facility': 'Centre Hospitalier Henri Duffaut', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}], 'overallOfficials': [{'name': 'Guillaume GRANIER, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre Hospitalier Henri Duffaut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Henri Duffaut - Avignon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}