Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 6:02 AM
Study NCT ID:
NCT05667350
Status:
UNKNOWN
Last Update Posted:
2022-12-30
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, white blood cells and fresh frozen tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 492}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sensitivity and specificity of the combined model in detection of biliary tract cancers.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers.', 'timeFrame': '24 months'}, {'measure': 'The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers.', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants will be recruited from participating medical centers and assigned into two arms, including participants with new diagnosis of biliary tract cancer and benign biliary tract diseases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Cancer Arm Participants:\n\n* Age 40-75 years at the day of consenting to the study.\n* Able to provide a written informed consent\n* Pathologically confirmed biliary tract cancers.\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* 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 cancers.\n* With other known malignant tumors or multiple primary tumors.\n\nInclusion Criteria for Benign Arm Participants:\n\n* Age 40-75 years at the day of consenting to the study.\n* Able to provide a written informed consent.\n* Confirmed diagnosis of benign biliary tract diseases.\n* No prior radical treatment of the benign diseases prior to study blood draw.\n\nExclusion Criteria for Benign Arm 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 cancers.\n* Confirmed diagnosis of malignancies or precancerous lesion.\n* A history of malignant tumors.'}, 'identificationModule': {'nctId': 'NCT05667350', 'briefTitle': 'AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Hepatobiliary Surgery Hospital'}, 'officialTitle': 'Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study', 'orgStudyIdInfo': {'id': 'RSCD2021021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer arm', 'description': 'Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.', 'interventionNames': ['Other: Blood drawing']}, {'label': 'Benign disease arm', 'description': 'Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.', 'interventionNames': ['Other: Blood drawing']}], 'interventions': [{'name': 'Blood drawing', 'type': 'OTHER', 'description': 'Blood drawing before anti-cancer therapy', 'armGroupLabels': ['Cancer arm']}, {'name': 'Blood drawing', 'type': 'OTHER', 'description': 'Blood drawing before radical treatment', 'armGroupLabels': ['Benign disease arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Leibo Xu, MD/PhD', 'role': 'CONTACT'}, {'name': 'Yuzi Zhang, MD/PhD', 'role': 'CONTACT', 'email': 'Z_Zhangyuzi@163.com', 'phone': '+86-021-60293798'}], 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Li, MD/PhD', 'role': 'CONTACT', 'email': 'libinjeff@126.com', 'phone': '+86-021-65564166'}, {'name': 'Yuzi Zhang, MD/PhD', 'role': 'CONTACT', 'email': 'Z_Zhangyuzi@163.com', 'phone': '+86-021-60293798'}], 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Bin Li, MD/PhD', 'role': 'CONTACT', 'email': 'libinjeff@126.com', 'phone': '+86-021-65564166'}, {'name': 'Yuzi Zhang, MD/PhD', 'role': 'CONTACT', 'email': 'Z_Zhangyuzi@163.com', 'phone': '+86-021-60293798'}], 'overallOfficials': [{'name': 'Xiaoqing Jiang, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}, {'name': 'Bin Li, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Burning Rock Bioengineering Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiaoqing Jiang', 'investigatorAffiliation': 'Eastern Hepatobiliary Surgery Hospital'}}}}