Transcriptomic Signatures in Gastric Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

— GAC  

Official title:

Exploring the Transcriptomic Signatures and Their Relevance in Gastric Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319392
• Other study ID #: 2021-240-PhD-EXP-42
• Status: Recruiting
• Start date: August 6, 2021
• Est. completion date: October 6, 2025

Study information

• Verified date: April 2022
• Source: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Contact: Raghavendra Lingaiah
• Phone: +91-522-2494250
• Email: raghulingaiah[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 6, 2025
• Est. primary completion date: April 6, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Diagnostic Test:
• Observational study
Exploration of transcriptomic signatures related to tumor microenvironment having a significant role in prognosis of gastric adenocarcinoma patients

Locations

Country	Name	City	State
India	Sanjay Gandhi Postgraduate Institute of Medical Sciences	Lucknow	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Sanjay Gandhi Postgraduate Institute of Medical Sciences

Country where clinical trial is conducted

India, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: BSR20200980. doi: 10.1042/BSR20200980. — View Citation

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 ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Patient risk stratification based on correlation between gene expression and overall survival	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