NCT05319392

Brief Summary

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.

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
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 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

Study Start

First participant enrolled

August 6, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

3.7 years

First QC Date

March 31, 2022

Last Update Submit

April 8, 2022

Conditions

Gastric Adenocarcinoma

Keywords

Gastric cancerTumor microenvironmentTranscriptomicsDifferential gene expression

Outcome Measures

Primary Outcomes (4)

  • Transcriptome profiling of Gastric adenocarcinoma

    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

    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

    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

    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 Outcomes (1)

  • Patient risk stratification based on correlation between gene expression and overall survival

    Range of 6 months to 5 years of patient recruitment

Study Arms (1)

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

Interventions

Observational studyDIAGNOSTIC_TEST

Exploration of transcriptomic signatures related to tumor microenvironment having a significant role in prognosis of gastric adenocarcinoma patients

Patients with Gastric Adenocarcinoma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Related Publications (6)

  • Ahn B, Chae YS, Kim CH, Lee Y, Lee JH, Kim JY. Tumor microenvironmental factors have prognostic significances in advanced gastric cancer. APMIS. 2018 Oct;126(10):814-821. doi: 10.1111/apm.12889.

    PMID: 30264431BACKGROUND

  • Zhang S, Zeng Z, Liu Y, Huang J, Long J, Wang Y, Peng X, Hu Z, Ouyang Y. Prognostic landscape of tumor-infiltrating immune cells and immune-related genes in the tumor microenvironment of gastric cancer. Aging (Albany NY). 2020 Sep 23;12(18):17958-17975. doi: 10.18632/aging.103519. Epub 2020 Sep 23.

    PMID: 32969836BACKGROUND

  • Qiu XT, Song YC, Liu J, Wang ZM, Niu X, He J. Identification of an immune-related gene-based signature to predict prognosis of patients with gastric cancer. World J Gastrointest Oncol. 2020 Aug 15;12(8):857-876. doi: 10.4251/wjgo.v12.i8.857.

    PMID: 32879664BACKGROUND

  • Ren N, Liang B, Li Y. Identification of prognosis-related genes in the tumor microenvironment of stomach adenocarcinoma by TCGA and GEO datasets. Biosci Rep. 2020 Oct 30;40(10):BSR20200980. doi: 10.1042/BSR20200980.

    PMID: 33015704BACKGROUND

  • Cai WY, Dong ZN, Fu XT, Lin LY, Wang L, Ye GD, Luo QC, Chen YC. Identification of a Tumor Microenvironment-relevant Gene set-based Prognostic Signature and Related Therapy Targets in Gastric Cancer. Theranostics. 2020 Jul 9;10(19):8633-8647. doi: 10.7150/thno.47938. eCollection 2020.

    PMID: 32754268BACKGROUND

  • Li T, Gao X, Han L, Yu J, Li H. Identification of hub genes with prognostic values in gastric cancer by bioinformatics analysis. World J Surg Oncol. 2018 Jun 19;16(1):114. doi: 10.1186/s12957-018-1409-3.

    PMID: 29921304BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Surgically resected fresh tissue samples and FFPE blocks of surgical specimens from gastric adenocarcinoma patients

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Raghavendra Lingaiah

    SGPGIMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raghavendra Lingaiah

CONTACT

+91-522-2494250raghulingaiah@gmail.com

Shalini Singh

CONTACT

shal_singh@yahoo.co.uk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor (Clinical chemistry)

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

August 6, 2021

Primary Completion

April 6, 2025

Study Completion

October 6, 2025

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)