ctDNA for Prediction of Relapse in Gastric Cancer

February 25, 2019 updated by: Ruihua Xu, Sun Yat-sen University

A Prospective Study of Blood Circulating Tumor DNA for the Prediction of Postoperative Relapse in Early and Intermediate-Stage Gastric Cancer

Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is one of the common malignant tumors in China, withrelatively high incident rate and mortality among the population. 95% of the gastric cancer is adenocarcinoma. 70% of the patients at the early stage show no obvious symptom, and only small number of them has nausea, vomiting, or symptoms that are similar to the of peptic ulcer disease.

Surgery is the conventional treatment option for early and middle stage gastric cancer, but postoperative relapse is the major issue. Currently, the only proven effective chemotherapies for gastric cancer are the taxane and platinum-based combination therapies. Also due to its molecular heterogeneity, the prognosis of gastric caner is highly varied among the patients. Therefore,there are not many effective targeting therapies available for the treatment of gastric cancer; and currently, trastuzumab and apatinib are the only two targeting drugs that have been clinically approved by CFDA.

Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation (2, 3). Although the mechanisms of its release have not been fully addressed, most reports considered apoptosis and/or necrosis of tumor cells as its main sources, which makes it a genomic reservoir of different tumor clones (4). Also, as its half-life is up to hours, ctDNA is reflecting the most up-to-date status of tumor genome(5). Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring.

By monitoring the serum ctDNA mutational profile using Next Generation Sequencing (NGS), the present clinical trial aims to elucidate the correlation between the serum ctDNA status and the prognosis of patients with early and intermediate-stage gastric cancer upon surgical treatment, and explore the possibility of clinical utility of serum ctDNA as a clinical index to predict postoperative relapse. Moreover, by comparing the molecular profiles of patients with different prognosis, we may also screen out the molecular markers related to the prognosis of gastric cancer.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Medical Oncology,Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This is a prospective clinical study collaborated with Geneseeq Technology Inc.200 of patients are planned. Total duration of the study is expected to be 2 years. The fresh tumor tissues/biopsies of each patient will be collected during the surgical treatment. The peripheral blood samples of each patient will be collected at the following time points: 1) prior to the surgical treatment; 2) 1 week after the surgical treatment; 3)every three months until disease progression or the end of the study. The collected fresh tumor tissues/biopsies or formalin fixed paraffin embedded (FFPE) blocks/sections, and peripheral blood samples will be further subjected for NGS analysis and NGS-based ctDNA mutation profiling, respectively.

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age at first visit.
  2. Patients must have histologically confirmed early or intermediate-stage gastric cancer.
  3. Patients need to have surgical treatment.
  4. Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
  5. Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
  6. Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

  1. Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
  2. Patients with severe infection will be excluded.
  3. Patients with other serious disease besides early or intermediate-stage gastric cancer will be excluded.
  4. Pregnant women will be excluded.
  5. Patients who are alcoholic or drug abusers will be excluded.
  6. Patients with a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value
Time Frame: through study completion, an average of 2 years
the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognostic molecular markers
Time Frame: through study completion, an average of 2 years
to screen out the molecular markers related to the prognosis of gastric cancer by comparing the molecular profiles of patients with different prognosis
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

May 14, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ctDNA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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