Potential Clinical Utilities of Circulating Tumor DNA in Gastric Cancer

NCT04000425 | Unknown

• 1 other identifier: ZSGC-005
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the potential clinical utility of ctDNA in the field of gastric cancer treatment,especially the usage of an indicator of MRD(minimal residual disease) in post radical gastrectomy patients. The primary purpose of this trial is to demonstrate if the postoperative ctDNA analysis could be used as an indicator of MRD or adjuvant chemotherapy response in advanced gastric cancer after radical gastrectomy.The second purpose is to describe the profile of ctDNA in gastric cancer.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Circulating Tumor DNA; Minimal Residue Disease; Chemotherapy Response

Outcome Measures

Primary Outcomes (2)

• Description of disease recurrence risk according to first positive ctDNA detection

  Time is measured from first positive ctDNA detection to disease-free survival event.

  2 years

• Description of ctDNA changing to adjuvant chemotherapy response

  For subjects with postoperative positive ctDNA, time is measured from first adjuvant chemotherapy to first negative ctDNA detection.

  2 years

Secondary Outcomes (2)

• Leading time between ctDNA detection and disease recurrence detected by conventional methods

  2 years

• The ctDNA level/mutations in gastric cancer preoperatively

  Within 7 days before operation

Study Arms (1)

ctDNA detection

The blood samples for ctDNA and other tumor markers (such as CEA, et al.) will be first collected within 7 days before surgery, and then be tested after radical gastrectomy in scheduled interval.

Combination Product: AVENIO ctDNA surveillance kit

Interventions

AVENIO ctDNA surveillance kit COMBINATION_PRODUCT

AVENIO circulating tumor DNA (ctDNA) Analysis Kits is a portfolio of three next-generation sequencing (NGS) liquid biopsy assay kits for oncology research: the AVENIO ctDNA Targeted Kit, Expanded Kit and Surveillance Kit.

ctDNA detection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stomach adenocarcinoma patients who plan to receive radical gastrectomy and continuous circulating tumor DNA monitoring

You may qualify if:

• Male or female patients age 18 - 75.
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
• Histologically proven primary stomach adenocarcinoma with Lauren type by gastroscopic biopsy before operation.
• Clinical stage is cT3/4N+M0 and the tumor is resectable in initial evaluation.
• No preoperative tumor therapy, including chemotherapy, radiotherapy, et al.
• No concomitant other malignant tumor or treated malignant tumor within last five years.
• Signed informed consent.
• Consent to provide research blood/tissue samples and clinicopathological information.

You may not qualify if:

• Radical gastrectomy was found cannot be achieved during operation due to metastasis or adjacent organ invasion.
• Only preoperative or postoperative blood sample was harvest or qualified.
• No qualified paired tissue samples.
• No complete clinicopatholoical information and follow-up.
• Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

ZhongShan hospital FuDan university

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhaoqing Tang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoqing Tang, MD

CONTACT

86-21-64041990; tang.zhaoqing@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 27, 2019
• Study Start: December 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: May 31, 2021
• Last Updated: June 27, 2019

Record last verified: 2019-06

Locations

CN (1)