NCT07403916

Brief Summary

Next-generation sequencing (NGS) and biomarkers play a key role in the diagnosis and personalized therapy of gastric cancer. These technologies provide a deep understanding of the molecular basis of the disease. NGS allows simultaneous analysis of multiple genes, identifying mutations and changes in their expression. In case of stomach cancer, this makes it possible to identify specific mutations to determine prognosis and treatment choice, study the genomic profiles of patients to find targets for targeted and immunotherapy. The use of NGS and biomarkers allows the development of individualized treatment regimens, increasing effectiveness and reducing side effects. Biomarker analysis also helps to track the progression of the disease and identify patients at high risk of relapse. The study of molecular genetic markers in tumor tissues, as well as the influence of genetic and age-related factors, is an important scientific and clinical task. Solving this problem will create a personalized approach to patient management. This work examines the influence of age on the choice of treatment tactics and prognosis in patients with resectable gastric cancer. The main focus is on the analysis of surgical, chemotherapeutic, topographic, pathomorphological, and molecular genetic correlations in various age groups.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

January 10, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Gastric cancer surgeryNext-generation sequencingGastric cancer treatment

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 months

Secondary Outcomes (3)

  • Mutational burden and genomic instability features assessed by NGS

    3 months

  • Spectrum of somatic mutations identified by NGS

    3 months

  • Disease free survival

    3 months

Study Arms (4)

Уoung-adult age group

age 18-44 yr.

Diagnostic Test: Next-generation sequencing

Middle-aged group

age 45-59 yr.

Diagnostic Test: Next-generation sequencing

Eldery age group

age 60-74 yr.

Diagnostic Test: Next-generation sequencing

Senior age group

age \> 75 yr.

Diagnostic Test: Next-generation sequencing

Interventions

Technology for determining the sequence of DNA to study genetic variation associated with diseases or other biological phenomena

Eldery age groupMiddle-aged groupSenior age groupУoung-adult age group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients with clinically documented primary gastric cancer undergoing elective surgery with curative intent

You may qualify if:

  • Patients with histologically confirmed diagnosis of gastric cancer
  • The resectable stage of the disease (I-III)
  • Availability of complete clinical data, including age, gender, stage of the disease, concomitant diseases, treatment tactics and outcomes
  • Indicated radical surgical intervention both at the first stage and after neoadjuvant chemotherapy
  • Localization of the tumor: Type II-III cardioesophageal junction according to Siewert, upper, middle and lower third of the body, angle of the stomach or antrum (U,M,L-level according to the Japanese classification)

You may not qualify if:

  • The presence of metastases in distant organs at the time of diagnosis
  • Primary-multiple tumors
  • Diagnostic and palliative surgery
  • Incomplete clinical data
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

P.Herzen Moscow Oncological Research Institute

Moscow, Russia

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Andrey Ryabov, MD, PhD

    P.Herzen Moscow Oncological Research Institute

    STUDY DIRECTOR
  • Vakhtang Begiashvili, PhD student

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR
  • Vladimir Khomyakov, MD, PhD

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR
  • Nadezhda Volchenko, MD, PhD

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR
  • Shatalov Peter, PhD

    P.Herzen Moscow Oncological Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

January 10, 2020

Primary Completion

December 31, 2025

Study Completion

June 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations