Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT04822792
Status:
UNKNOWN
Last Update Posted:
2021-06-02
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT
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': 'ESTIMATED', 'count': 11879}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-29', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers', 'timeFrame': '22 months'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases', 'timeFrame': '22 months'}, {'measure': 'Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants', 'timeFrame': '22 months'}, {'measure': 'Sensitivity and specificity of early detection of cancer in different stages', 'timeFrame': '22 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Liquid biopsy', 'Cell-free DNA (cfDNA)', 'Early detection'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, 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 re recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancies or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.', 'eligibilityCriteria': 'Inclusion Criteria for All the Participants:\n\n* Ability to provide a written informed consent\n* 40-75 years old\n\nExclusion Criteria for All the Participants:\n\n* Inability to comply with study procedures\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 one of the 22 types of malignancies within 42 days prior to study blood draw\n* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw\n\nExclusion Criteria for Cancer Arm Participants:\n\n* Known prior diagnosis of malignancies\n* Other current malignant diseases or multiple primary tumors\n* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease by histopathological assessments, 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\nInclusion Criteria for Benign Diseases Arm Participants:\n\n* Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw\n* No prior treatment of benign diseases prior to study blood draw\n\nExclusion Criteria for Benign Diseases Arm Participants:\n\n* History of malignancies\n* Current malignancies or precancerous lesions\n* No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign\n\nInclusion Criteria for Non-tumor (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 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 Non-tumor (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': 'NCT04822792', 'acronym': 'PRESCIENT', 'briefTitle': 'Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RSCD2020002'}}, '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': 'Benign Diseases Arm', 'description': 'Participants with benign diseases corresponding to the tumor types in the Cancer Arm, 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 disease, 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': ['Benign Diseases Arm', 'Cancer Arm', 'Healthy Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiachen Xu, M.D.', 'role': 'CONTACT', 'email': 'XJCwelcome@126.com', 'phone': '+86-10-87788029'}, {'name': 'Jie Wang, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jiachen Xu, M.D.', 'role': 'CONTACT', 'email': 'XJCwelcome@126.com', 'phone': '+86-010-87788029'}, {'name': 'Shangli Cai, Ph.D.', 'role': 'CONTACT', 'email': 'shangli.cai@brbiotech.com', 'phone': '+86-021-61631938'}], 'overallOfficials': [{'name': 'Jie Wang, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Burning Rock Dx Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}