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

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ClinicalTrials.gov Identifier: NCT03076502
Recruitment Status : 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

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.

Condition or disease
Neoplasms, Gastrointestinal

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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pathological diagnosis [ Time Frame: intraoperative ]
    Sensitivity and specificity


Secondary Outcome Measures :
  1. Tumor status(worse/ maintain/ better) [ Time Frame: 2 years ]
    the level of ct-DNA compared with the tumor burden


Biospecimen Retention:   Samples With DNA
Peripheral blood samples; Portal vein blood samples; Tumor tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected gastrointestinal and hepatobiliary pancreatic cancer.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076502


Contacts
Contact: Tao Chen, M.D. +8613601779874 dr_chentao78@163.com

Sponsors and Collaborators
RenJi Hospital
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

Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03076502     History of Changes
Other Study ID Numbers: ctDNA-GI
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RenJi Hospital:
ctDNA
Gastrointestinal Cancer
ROS
Hepatobiliary Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases