NCT02887612

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3.2 years

First QC Date

May 14, 2016

Last Update Submit

February 25, 2019

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Positive Predictive Value

    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 Outcomes (1)

  • prognostic molecular markers

    through study completion, an average of 2 years

Interventions

ctDNA testOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Male or female ≥ 18 years of age at first visit.
  • Patients must have histologically confirmed early or intermediate-stage gastric cancer.
  • Patients need to have surgical treatment.
  • Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
  • Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
  • 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.

You may not qualify if:

  • Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
  • Patients with severe infection will be excluded.
  • Patients with other serious disease besides early or intermediate-stage gastric cancer will be excluded.
  • Pregnant women will be excluded.
  • Patients who are alcoholic or drug abusers will be excluded.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • Jahr S, Hentze H, Englisch S, Hardt D, Fackelmayer FO, Hesch RD, Knippers R. DNA fragments in the blood plasma of cancer patients: quantitations and evidence for their origin from apoptotic and necrotic cells. Cancer Res. 2001 Feb 15;61(4):1659-65.

    PMID: 11245480BACKGROUND

  • Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.

    PMID: 25646427BACKGROUND

  • Stroun M, Lyautey J, Lederrey C, Olson-Sand A, Anker P. About the possible origin and mechanism of circulating DNA apoptosis and active DNA release. Clin Chim Acta. 2001 Nov;313(1-2):139-42. doi: 10.1016/s0009-8981(01)00665-9.

    PMID: 11694251BACKGROUND

  • Yu SC, Lee SW, Jiang P, Leung TY, Chan KC, Chiu RW, Lo YM. High-resolution profiling of fetal DNA clearance from maternal plasma by massively parallel sequencing. Clin Chem. 2013 Aug;59(8):1228-37. doi: 10.1373/clinchem.2013.203679. Epub 2013 Apr 19.

    PMID: 23603797BACKGROUND

  • Yuan SQ, Nie RC, Huang YS, Chen YB, Wang SY, Sun XW, Li YF, Liu ZK, Chen YX, Yao YC, Xu Y, Qiu HB, Liang Y, Wang W, Liu ZX, Zhao Q, Xu RH, Zhou ZW, Wang F. Residual circulating tumor DNA after adjuvant chemotherapy effectively predicts recurrence of stage II-III gastric cancer. Cancer Commun (Lond). 2023 Dec;43(12):1312-1325. doi: 10.1002/cac2.12494. Epub 2023 Oct 14.

    PMID: 37837629DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Rui-hua Xu

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang, MD.,PhD.

CONTACT

86-2087343804

Shuang-zhen Chen, BS.

CONTACT

86-2087343795

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.,PhD.

Study Record Dates

First Submitted

May 14, 2016

First Posted

September 2, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

CN(1)