Clinical trial NCT03076502: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms, Gastrointestinal
Keywords: ctDNA
Gastrointestinal Cancer
ROS
Hepatobiliary Pancreatic Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
name: The University of Queensland
First posted: 2017-03-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected 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.

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.

Primary outcomes:
measure: Pathological diagnosis
timeFrame: intraoperative
Secondary outcomes:
measure: Tumor status（worse/ maintain/ better）
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: JIAN WANG, M.D.
role: PRINCIPAL_INVESTIGATOR
References: