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
|Condition or disease|
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|
|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|
- Pathological diagnosis [ Time Frame: intraoperative ]Sensitivity and specificity
- Tumor status（worse/ maintain/ better） [ Time Frame: 2 years ]the level of ct-DNA compared with the tumor burden
Biospecimen Retention: Samples With DNA
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
|Contact: Tao Chen, M.D.||+firstname.lastname@example.org|
|Principal Investigator:||JIAN WANG, M.D.||Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University|