Transcriptomic Signatures in Gastric Adenocarcinoma

NCT ID: NCT05319392

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-06

Study Completion Date

2025-10-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastric Adenocarcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observational study

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Observational study

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanjay Gandhi Postgraduate Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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raghavendra

Assistant professor (Clinical chemistry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raghavendra Lingaiah

Role: PRINCIPAL_INVESTIGATOR

SGPGIMS

Locations

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Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Raghavendra Lingaiah

Role: CONTACT

+91-522-2494250

Shalini Singh

Role: CONTACT

Facility Contacts

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Raghavendra Lingaiah

Role: primary

+91-522-2494250

Shalini Singh

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30264431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32969836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32879664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33015704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32754268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29921304 (View on PubMed)

Other Identifiers

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2021-240-PhD-EXP-42

Identifier Type: -

Identifier Source: org_study_id

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