- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403916
Influence of Age on the Choice of Treatment and Prognosis in Patients With Resectable Gastric Cancer
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Gastric cancer remains one of the most important malignant tumors with significant geographical and regional differences in prevalence. Despite the decrease in the incidence of gastric cancer in advanced economies, this pathology still ranks fifth among patients with malignant neoplasms. As for cancer mortality rates, stomach cancer ranks third. Stomach cancer continues to be one of the most significant oncological diseases in the world, ranking fifth in terms of prevalence according to global statistics from GLOBOCAN 2022.
Modern medicine uses diagnostic technology - Next-generation sequencing (NGS), and biomarkers play an important role in the diagnosis, prognosis, and treatment of stomach cancer. These technologies provide a deep understanding of the molecular mechanisms underlying the disease and open up new possibilities for personalized therapy. NGS allows simultaneous analysis of multiple genes and detection of mutations, changes in gene expression and other genetic features. In the context of stomach cancer, next-generation sequencing allows for identification of mutations: Detection of specific mutations associated with stomach cancer can help determine prognosis and select appropriate treatment, study of the genomic profiles of patients: To identify potential targets for therapy, including immune and targeted drugs.
With the help of NGS and biomarkers, doctors can develop individualized treatment regimens for different age groups, which increases the effectiveness of therapy and reduces side effects. Biomarker analysis allows you to track the progression of cancer and identify patients with a high risk of recurrence. The study and determination of molecular genetic markers in tumor tissues, as well as the analysis of genetic and age-related factors influencing the development of gastric cancer, is an important scientific and clinical task. Solving this problem may allow us to develop a personalized approach to patient management.
This scientific paper will address the issue of the influence of age on the choice of treatment tactics and prognosis in patients with resectable gastric cancer. The main focus is on surgical, chemotherapeutic, topographic, pathomorphological, and molecular genetic correlations of various age groups in resectable gastric cancer.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Moscow, Russia
- P.Herzen Moscow Oncological Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- The presence of metastases in distant organs at the time of diagnosis
- Primary-multiple tumors
- Diagnostic and palliative surgery
- Incomplete clinical data
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Уoung-adult age group
age 18-44 yr.
|
Technology for determining the sequence of DNA to study genetic variation associated with diseases or other biological phenomena
|
|
Middle-aged group
age 45-59 yr.
|
Technology for determining the sequence of DNA to study genetic variation associated with diseases or other biological phenomena
|
|
Eldery age group
age 60-74 yr.
|
Technology for determining the sequence of DNA to study genetic variation associated with diseases or other biological phenomena
|
|
Senior age group
age > 75 yr.
|
Technology for determining the sequence of DNA to study genetic variation associated with diseases or other biological phenomena
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mutational burden and genomic instability features assessed by NGS
Time Frame: 3 months
|
3 months
|
|
Spectrum of somatic mutations identified by NGS
Time Frame: 3 months
|
3 months
|
|
Disease free survival
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Andrey Ryabov, MD, PhD, P.Herzen Moscow Oncological Research Institute
- Principal Investigator: Vladimir Khomyakov, MD, PhD, P.Herzen Moscow Oncological Research Institute
- Principal Investigator: Vakhtang Begiashvili, PhD student, 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Molecular Analysis
-
Southwest Regional Wound Care CenterCompleted
-
Seoul National University HospitalRecruitingPancreatic Cyst | Molecular, Chemical Analysis of Cystic FluidKorea, Republic of
-
Universidad de MagallanesUniversity of ChileCompletedMetabolic Syndrome | HIV | Microbiome | Single Cell Sequencing Technology | Sequence Analysis | Flow Cytometry | Molecular BiologyChile
-
University of AlbertaRecruitingValidation Study of Molecular Diagnostic System | Development of Reporting System for Molecular Diagnosis | Incorporate Molecular Diagnosis Into Diagnostic StandardsUnited States, Switzerland, Austria, Canada, Czechia, France, Germany, Ireland, Spain, United Kingdom, Croatia, Poland, Slovenia, South Korea
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMolecular ImagingUnited States
-
M.D. Anderson Cancer CenterPhase One FoundationWithdrawn
-
Istanbul University - CerrahpasaCompletedGait Analysis | 3D Gait AnalysisTurkey
-
Balance TherapeuticsCompletedMolecular Mechanisms of Pharmacological ActionUnited Kingdom
-
University of California, San FranciscoRecruitingMicrobiome AnalysisUnited States
-
Medacta International SAActive, not recruiting
Clinical Trials on Next-generation sequencing
-
Asan Medical CenterRecruitingPancreatic Cancer | Chemotherapy Effect | Genetic ChangeKorea, Republic of
-
Qingyuan ZhanNot yet recruiting
-
Konkuk University Medical CenterFoundation Medicine; Roche DiagnosticsRecruitingAdenocarcinoma of Lung | EGFR Activating MutationKorea, Republic of
-
Xiangya Hospital of Central South UniversityHunan Cancer Hospital; The Third Xiangya Hospital of Central South University; Hunan Provincial People's Hospital and other collaboratorsCompletedBladder Cancer | Urine | Diagnosis | BiomarkerChina
-
University Hospital HeidelbergFraunhofer Institute for Interfacial Engineering and Biotechnology; Dietmar...CompletedSepsis | Septic ShockGermany
-
Rothman Institute OrthopaedicsEnrolling by invitation
-
Huashan HospitalChildren's Hospital of Fudan University; Shanghai Jiao Tong University Affiliated...UnknownInfectious Disease | Next Generation SequencingChina
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingThis Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in BileChina
-
Aarhus University HospitalRecruiting
-
Shanghai Pulmonary Hospital, Shanghai, ChinaRecruitingIdiopathic Interstitial Pneumonias | Cryptogenic Organizing PneumoniaChina