Transcriptomic Signatures in Gastric Adenocarcinoma (GAC)

April 8, 2022 updated by: raghavendra, Sanjay Gandhi Postgraduate Institute of Medical Sciences

Exploring the Transcriptomic Signatures and Their Relevance in Gastric Adenocarcinoma

Gastric Adenocarcinoma (GAC) accounting for the major percentage of all stomach malignancies is associated with a poor overall survival of 25-30% despite the advancement in treatment strategies. Several factors associated with tumor microenvironment (TME) are thought to play an important role in tumorigenesis and acquired chemoresistance to therapies that are not otherwise addressed by the comprehensive molecular classification of GAC given by TCGA and ACRG. In the present study investigators intend to do transcriptome profiling of GAC tumor tissue and adjacent normal tissue to investigate differentially expressed genes between the two in relation to TME which might help in identification of gene signatures that are clinically relevant with survival outcome in Gastric Adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study on Gastric adenocarcinoma is retrospective as well as prospective that will be conducted at SGPGIMS, Lucknow, India. Patients undergoing gastric resection at the department of surgical gastroenterology who are diagnosed with GAC based on the endoscopic biopsy in the department of pathology will be recruited for the study. For the retrospective part of study, cases will be selected based on histological findings retrieved from hospital information system and patient records.

For sample collection, surgically resected fresh specimens will be collected in RNAlater and stored at -80⁰C. Archived formalin fixed paraffin embedded (FFPE) tissue blocks for retrospective cases will be retrieved and reviewed histopathologically. After a confirmed diagnosis of GAC, tissues will be processed to obtain tumor and normal tissue for experimental part.

RNA from the tumor and normal area will be extracted from FFPE blocks and fresh tissue specimens. Whole transcriptomic next generation sequencing will be performed after successful quality check, library preparation and amplification. The gene expression data obtained from sequencing will be bioinformatically analyzed to elucidate differential gene expression between tumor and adjacent normal tissue in relation to TME. The significantly differentially expressed genes between the tumor and normal areas will be annotated and identified using bioinformatic packages for gene annotation. Using statistical analysis, the differentially expressed genes will be correlated with the patient's clinical features and outcome to identify TME genes with significant prognostic value.

Study Type

Observational

Enrollment (Anticipated)

48

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • India
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed with distal Gastric Adenocarcinoma at SGPGIMS will be recruited for this study

Description

Inclusion Criteria:

  • Patients with origin of tumor in distal part of stomach
  • Patients who underwent Total or partial Gastrectomy after Biopsy examination
  • Availability of follow up in Radiotherapy or Gastro department
  • Availability of FFPE gastrectomy specimen tissue of selected cases in Histopathology

Exclusion Criteria:

  • Patients with origin of tumor in proximal part of stomach
  • Patients with only biopsy available
  • Patients whose follow-up is not available
  • Unavailability of FFPE tissue blocks

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Gastric Adenocarcinoma
Patients with origin of tumor in distal part of stomach who underwent total or partial gastrectomy after biopsy examination with availability of follow-up and archived FFPE tissue will be considered for this study.
Diagnostic test: Observational study
Exploration of transcriptomic signatures related to tumor microenvironment having a significant role in prognosis of gastric adenocarcinoma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptome profiling of Gastric adenocarcinoma
Time Frame: Range of 6 months to 5 years of patient recruitment
To obtain gene expression data of cancerous and normal tissue through RNA - sequencing
Range of 6 months to 5 years of patient recruitment
Differential gene expression analysis in Gastric adenocarcinoma
Time Frame: Range of 6 months to 5 years of patient recruitment
To determine differentially expressed gene between tumor and normal tissue through bioinformatic analysis of gene expression data
Range of 6 months to 5 years of patient recruitment
Influence of tumor microenvironment on gene expression profile of gastric adenocarcinoma
Time Frame: Range of 6 months to 5 years of patient recruitment
To identify tumor microenvironment related genes and their functional annotation using bioinformatic packages
Range of 6 months to 5 years of patient recruitment
Correlation of tumor microenvironment related genes with patient's clinical features
Time Frame: Range of 6 months to 5 years of patient recruitment
To correlate differentially expressed tumor microenvironment related gene with outcome in patients to identify genes significantly related with overall survival
Range of 6 months to 5 years of patient recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient risk stratification based on correlation between gene expression and overall survival
Time Frame: Range of 6 months to 5 years of patient recruitment
To stratify patients based on gene signatures related to overall survival in gastric adenocarcinoma patients
Range of 6 months to 5 years of patient recruitment

Collaborators and Investigators

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

Sponsor

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Investigators

  • Principal Investigator: Raghavendra Lingaiah, SGPGIMS

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 (Actual)

August 6, 2021

Primary Completion (Anticipated)

April 6, 2025

Study Completion (Anticipated)

October 6, 2025

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-240-PhD-EXP-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Gastric Adenocarcinoma

Clinical Trials on Observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe