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The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03076502
Recruitment Status : Unknown
Verified March 2017 by RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborators:
Shanghai Changzheng Hospital
The University of Queensland
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date March 5, 2017
First Posted Date March 10, 2017
Last Update Posted Date March 13, 2017
Estimated Study Start Date April 2017
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2017)
Pathological diagnosis [ Time Frame: intraoperative ]
Sensitivity and specificity
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03076502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 7, 2017)
Tumor status(worse/ maintain/ better) [ Time Frame: 2 years ]
the level of ct-DNA compared with the tumor burden
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer
Official Title The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer
Brief Summary 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.
Detailed Description

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.

ct-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.

It 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.

This 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral blood samples; Portal vein blood samples; Tumor tissue samples
Sampling Method Non-Probability Sample
Study Population Patients with suspected gastrointestinal and hepatobiliary pancreatic cancer.
Condition Neoplasms, Gastrointestinal
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 10, 2017)
500
Original Estimated Enrollment
 (submitted: March 7, 2017)
60
Estimated Study Completion Date April 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with suspected of gastrointestinal and hepatobiliary pancreatic cancer
  • Age from 18 - 80 years
  • No serious organic and mental illness;

Exclusion Criteria:

  • Pregnancy
  • No pathologic result
  • Suffering other malignancies at the same time.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03076502
Other Study ID Numbers ctDNA-GI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party RenJi Hospital
Study Sponsor RenJi Hospital
Collaborators
  • Shanghai Changzheng Hospital
  • The University of Queensland
Investigators
Principal Investigator: JIAN WANG, M.D. Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
PRS Account RenJi Hospital
Verification Date March 2017