Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06965335
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'liquid biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2025-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinicopathological features description', 'timeFrame': 'Apr 2024- Dec2026', 'description': 'Primaryto analyze clinicopathological features of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;'}, {'measure': 'overall survival and response to standard-of-care treatments analisys', 'timeFrame': 'Apr 2024- Dec2026', 'description': 'to analyze overall survival and response to standard-of-care treatments of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;'}], 'secondaryOutcomes': [{'measure': 'prevalence of colibactin assessment', 'timeFrame': 'Apr 2024- Dec2026', 'description': 'to assess the prevalence of colibactin in a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;'}, {'measure': 'perform a proteo-genomic characterization', 'timeFrame': 'Apr 2024- Dec2026', 'description': 'to perform a proteo-genomic characterization of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early-Onset Colorectal Cancer'], 'conditions': ['Colo-rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Observational, retrospective and prospective multicentric Italian study of patients diagnosed with colorectal cancer between age 18-40, aiming at underpinning the biology of vEO-CRC, including colibactin as well as a broader proteo-genomic characterization, to identify potential new therapeutic targets specifically directed to this peculiar subset of patients.', 'detailedDescription': "Clinicopathological features, and survival data will be pseudo-anonymized and collected through a dedicated ReDCap database by each participating center.\n\nColibactin assessment - FFPE samples will be stratified between colibactin-positive and negative ones using endpoint PCR. We will use primers flanking multiple regions of the colibactin genomic island (in particular, CLBO on the 5'-end, CLBI in the middle and CLBB on the 3'-end), since a fully intact sequence is required to produce a functional toxin 13. Amplicons will be around 100bp in length (150bp maximum) based on fragment size of plasma-derived DNA, and PCRs will be performed following a touchdown protocol. In a second approach, quantitative polymerase chain reaction (qPCR) will be performed to provide more quantitative correlation between colibactin and clinically relevant patient outcomes. We will amplify amplicons on the same regions used for the endpoint PCRs described above, and we will use primers flanking bacterial 16S sequence to estimate bacterial DNA content in plasma.\n\nProteogenomic assessment - An initial subset of 50 vEO-CRC and 50 SO-CRC will undergoing full proteomic assessment by mass spectrometry and whole genome sequencing (WGS). Potential findings on this initial subset of patients will be then validated by immunohistochemistry, polymerase chain reaction (PCR), Next Generation Sequencing (NGS) or In-situ ibridization (ISH). These translational analyses will be performed at Grande Ospedale Metropolitano Niguarda, University of Turin, Istituto Nazionale di Genetica Medica (INGM) in Milan andIFOM-ETS which will be the preclinical partners of this project.\n\nThanks to the collaboration with Azienda Territoriale Sanitaria (ATS)of the Metropolitan Area of Milan we will have access to epidemiological data regarding the real incidence of vEO CRC over the time.\n\nLiquid biopsy validation of proteogenomic findings from solid tissue - If available, 4 ml of plasma retrospectively collected through liquid biopsy and stored in participating centers will be queried to assess whether genomic or proteomic alterations can be identified in blood.\n\nPrimary objective:\n\n1. to analyze clinicopathological features of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;\n2. to analyze overall survival and response to standard-of-care treatments of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;\n\nSecondary objective :\n\n1. to assess the prevalence of colibactin in a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;\n2. to perform a proteo-genomic characterization of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later.\n\nExploratory objective :\n\n1\\. to assess if colibactin and potential proteo-genomic features of vEO-CRC can be also captured on plasma through liquid biopsy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal cancer pts', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Patients with diagnosis of colorectal cancer (vEO-CRC: 18-40 years of age), or SO-CRC diagnosed later than age 60;\n2. Informed consent signature from alivepatient;\n3. Availability of formalin-fixed paraffin embedded (FFPE) tumor samples (5 FFPE 4uM thick slides and 10 FFPE 10 uM thick slides) and/or fresh tumor tissue retrieved from a biopsy or surgical procedure performed as per clinical standard of care.'}, 'identificationModule': {'nctId': 'NCT06965335', 'acronym': 'HEBE', 'briefTitle': 'Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study - (The HEBE Study)', 'orgStudyIdInfo': {'id': '4528'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early-Onset(EO) Colorectal Cancer (CRC)', 'description': 'EO-CRC: 18-40 years of age at diagnosis', 'interventionNames': ['Biological: BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC']}, {'label': 'Standard onset (SO) Colorectal Cancer', 'description': 'SO-CRC diagnosed later than age 60', 'interventionNames': ['Biological: BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC']}], 'interventions': [{'name': 'BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC', 'type': 'BIOLOGICAL', 'description': 'Description of clinicophatological features of EO-CRC vs SO-CRC', 'armGroupLabels': ['Early-Onset(EO) Colorectal Cancer (CRC)', 'Standard onset (SO) Colorectal Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Siena, MD', 'role': 'CONTACT', 'email': 'salvatore.siena@ospedaleniguarda.it', 'phone': '+39 02 6444', 'phoneExt': '3695'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Salvatore Siena, MD', 'role': 'CONTACT', 'email': 'salvatore.siena@ospedaleniguarda.it', 'phone': '+39 02 6444', 'phoneExt': '3695'}, {'name': 'Andrea Sartore Bianchi, MD', 'role': 'CONTACT', 'email': 'andrea.sartorebianchi@ospedaleniguarda.it', 'phone': '+39 02 6444', 'phoneExt': '3695'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}