Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06440902
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-05-28', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of NeoRAS WT', 'timeFrame': 'up to 60 months', 'description': 'Proportion of occurrence of neoRAS WT'}], 'secondaryOutcomes': [{'measure': 'Objective response rate(ORR) of NeoRAS wild-type patients receiving anti-EGFR therapy', 'timeFrame': 'Follow-up was conducted for 2 years after enrollment', 'description': 'Objective response rate of NeoRAS wild-type patients receiving anti-EGFR (epidermal growth factor receptor) therapy'}, {'measure': 'Progression-free survival (PFS) in NeoRAS WT patients', 'timeFrame': 'Follow-up was conducted for 2 years after enrollment', 'description': 'Progression-free survival (PFS) : time from enrollment to disease progression from any cause'}, {'measure': 'Overall survival (OS) in NeoRAS WT patients', 'timeFrame': 'Follow-up was conducted for 2 years after enrollment', 'description': 'Overall survival (OS) : time from enrollment to death from any cause, loss of participants, and time of last follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Metastatic']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '37364334', 'type': 'BACKGROUND', 'citation': 'Osumi H, Takashima A, Ooki A, Yoshinari Y, Wakatsuki T, Hirano H, Nakayama I, Okita N, Sawada R, Ouchi K, Fukuda K, Fukuoka S, Ogura M, Takahari D, Chin K, Shoji H, Kato K, Ishizuka N, Boku N, Yamaguchi K, Shinozaki E. A multi-institutional observational study evaluating the incidence and the clinicopathological characteristics of NeoRAS wild-type metastatic colorectal cancer. Transl Oncol. 2023 Sep;35:101718. doi: 10.1016/j.tranon.2023.101718. Epub 2023 Jun 24.'}, {'pmid': '37064137', 'type': 'BACKGROUND', 'citation': 'Nicolazzo C, Magri V, Marino L, Belardinilli F, Di Nicolantonio F, De Renzi G, Caponnetto S, De Meo M, Giannini G, Santini D, Cortesi E, Gazzaniga P. Genomic landscape and survival analysis of ctDNA "neo-RAS wild-type" patients with originally RAS mutant metastatic colorectal cancer. Front Oncol. 2023 Mar 29;13:1160673. doi: 10.3389/fonc.2023.1160673. eCollection 2023.'}, {'pmid': '34153718', 'type': 'BACKGROUND', 'citation': 'Osumi H, Vecchione L, Keilholz U, Vollbrecht C, Alig AHS, von Einem JC, Stahler A, Striefler JK, Kurreck A, Kind A, Modest DP, Stintzing S, Jelas I. NeoRAS wild-type in metastatic colorectal cancer: Myth or truth?-Case series and review of the literature. Eur J Cancer. 2021 Aug;153:86-95. doi: 10.1016/j.ejca.2021.05.010. Epub 2021 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'Following systemic therapy in metastatic colorectal cancer(mCRC),RAS (including KRAS, NRAS and HRAS gene) status may change from a mutant(MT) to a wild-type(WT),a phenomenon known as "NeoRAS WT"mCRC.NeoRAS WT can be detected by longitudinal circulating tumor DNA(ctDNA) analysis.Therefore, this prospective phase II Study was design to explore the detection rate of peripheral blood ctDNA testing for NeoRAS WT and its guiding value for subsequent treatment for mCRC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Metastatic colorectal cancer with tissue RAS mutation-type;\n2. ECOG (Eastern Cooperative Oncology Group) performance score is 0-1;\n3. Obtaining informed consent;\n4. Surgical specimens or punctured tissue specimens containing tumors can be obtained; 10ml of peripheral blood can be obtained\n\nExclusion Criteria:\n\n1. The pathology was not confirmed by colonoscopy biopsy or biopsy of metastasis;\n2. Colorectal cancer patients with clinical stage I-III;Patients with RAS wild-type metastatic colorectal cancer confirmed by histological genetic testing;Lack of adequate organ functions, such as severe abnormalities in blood, liver and kidney function'}, 'identificationModule': {'nctId': 'NCT06440902', 'briefTitle': 'Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA: an Open, Prospective, Phase II Study', 'orgStudyIdInfo': {'id': 'ctDNA-neoRASCRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RAS mutated metastatic colorectal cancer', 'description': 'RAS mutated metastatic colorectal cancer were routinely treated after enrollment. When the disease progression was confirmed by imaging, peripheral blood ctDNA detection was performed to observe whether they were transformed into NeoRAS wild-type patients. If NeoRAS wild- type was detected, the anti-EGFR therapy may be considered as the following therapy for patients.', 'interventionNames': ['Drug: Cetuximab']}], 'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['C225'], 'description': 'Cetuximab is given In patients with NeoRAS WT', 'armGroupLabels': ['RAS mutated metastatic colorectal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junjie Peng, PhD', 'role': 'CONTACT', 'email': 'pengjj@shca.org.cn', 'phone': '+86 13917373312'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Junjie Peng, PhD', 'role': 'CONTACT', 'email': 'pengjj@shca.org.cn', 'phone': '+86 13917373312'}], 'overallOfficials': [{'name': 'Junjie Peng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Junjie Peng', 'investigatorAffiliation': 'Fudan University'}}}}