Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-30 @ 2:57 AM
Study NCT ID:
NCT04820868
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2021-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Unintrusive Detection of EaRly-stage Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2508}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model', 'timeFrame': '7 months'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer', 'timeFrame': '7 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Liquid biopsy', 'Cell-free DNA (cfDNA)', 'Early detection'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of malignancies and healthy participants.', 'eligibilityCriteria': 'Inclusion Criteria for All the Participants:\n\n* Ability to provide a written informed consent\n* 40-75 years old\n* Ability to comply with study procedures\n\nExclusion Criteria for All the Participants:\n\n* Pregnancy or lactating women\n* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant\n* Recipients of blood transfusion within 7 days prior to study blood draw\n* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer\n\nInclusion Criteria for Cancer Arm Participants:\n\n* Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.\n* No prior anti-cancer therapy (local or systematic) prior to study blood draw\n\nExclusion Criteria for Cancer Arm Participants:\n\n* Known prior or current diagnosis of other types of malignancies or multiple primary tumors\n* Diagnosis of benign diseases by histopathological assessments\n* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign\n* Non-small-cell lung cancer patients with ground-class nodularity by radiological examination\n* Diagnosis of precancerous lesions\n\nInclusion Criteria for Healthy Arm Participants:\n\n* No cancer-related symptoms or discomfort within 30 days prior to study blood draw\n* No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound\n* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants\n* No active hepatitis B or hepatitis C infection\n\nExclusion Criteria for Healthy Arm Participants:\n\n* Prior or ongoing treatment of cancer within 3 years prior to study blood draw\n* Clinically significant or uncontrolled comorbidities'}, 'identificationModule': {'nctId': 'NCT04820868', 'acronym': 'THUNDER', 'briefTitle': 'The Unintrusive Detection of EaRly-stage Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'A Blinded Prospective Study on Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection', 'orgStudyIdInfo': {'id': 'RSCD2020003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Arm', 'description': 'Participants with new diagnosis of cancer, from whom blood samples will be collected', 'interventionNames': ['Device: Multi-cancer early detection test']}, {'label': 'Healthy Arm', 'description': 'Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected', 'interventionNames': ['Device: Multi-cancer early detection test']}], 'interventions': [{'name': 'Multi-cancer early detection test', 'type': 'DEVICE', 'description': 'Blood collection and multi-cancer early detection test', 'armGroupLabels': ['Cancer Arm', 'Healthy Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Qiang Gao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Burning Rock Dx Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}