Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2026-01-10 @ 2:31 AM
Study NCT ID:
NCT03076502
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2017-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples; Portal vein blood samples; Tumor tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological diagnosis', 'timeFrame': 'intraoperative', 'description': 'Sensitivity and specificity'}], 'secondaryOutcomes': [{'measure': 'Tumor status（worse/ maintain/ better）', 'timeFrame': '2 years', 'description': 'the level of ct-DNA compared with the tumor burden'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ctDNA', 'Gastrointestinal Cancer', 'ROS', 'Hepatobiliary Pancreatic Cancer'], 'conditions': ['Neoplasms, Gastrointestinal']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the role of ct-DNA, PVT1 and reactive oxygen species (ROS) as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.', 'detailedDescription': 'Epidemiological surveys showed a significant increasing trend of gastrointestinal and hepatobiliary pancreatic cancer in recent years. How can make an early diagnosis of gastrointestinal and liver cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person\'s blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.\n\nct-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ct-DNA originates from tumoral tissue. Besides, ct-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.\n\nIt is known that levels of cellular ROS correlate with the aggressiveness of tumour cells and prognosis of patients. Cancer cells with increased endogenous ROS stress are more sensitive to anticancer agents and high levels of ROS generated by chemotherapeutic agents can induce cell death. Hence, ROS levels before and after chemotherapy in cancer cells can be an early indicator of treatment efficacy, which has the potential to shed new light on the choice of cancer therapy.\n\nThis study aims to evaluate the role of ct-DNA and ROS as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected gastrointestinal and hepatobiliary pancreatic cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected of gastrointestinal and hepatobiliary pancreatic cancer\n* Age from 18 - 80 years\n* No serious organic and mental illness;\n\nExclusion Criteria:\n\n* Pregnancy\n* No pathologic result\n* Suffering other malignancies at the same time.'}, 'identificationModule': {'nctId': 'NCT03076502', 'briefTitle': 'The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'ctDNA-GI'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tao Chen, M.D.', 'role': 'CONTACT', 'email': 'dr_chentao78@163.com', 'phone': '+8613601779874'}], 'overallOfficials': [{'name': 'JIAN WANG, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, {'name': 'The University of Queensland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}