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AzTrials

Gastric AdenocarcinomaGACNCT05319392

Transcriptomic Signatures in Gastric Adenocarcinoma

An observational study of Gastric Adenocarcinoma, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Observational study
How many people
48 participants
Where
1 siteIndia
Study dates
6 Aug 2021to 6 Oct 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Raghavendra Lingaiah contact

+91-522-2494250

raghulingaiah@gmail.com

Shalini Singh contact

shal_singh@yahoo.co.uk

India1 site, 1 recruiting

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

    Raghavendra Lingaiah, +91-522-2494250, raghulingaiah@gmail.com

    Shalini Singh, shal_singh@yahoo.co.uk

    Recruiting

Other trials in India

About this study

Official title: 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.

Read the 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.

Being tested
Observational study
Keywords
Gastric cancer, Tumor microenvironment, Transcriptomics, Differential gene expression
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational studyDiagnostic test

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

Study groups in NCT05319392
Study groupRoleWhat they receive
Patients with Gastric AdenocarcinomaPatients 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.
Receives: Diagnostic Test: Observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transcriptome profiling of Gastric adenocarcinoma

    To obtain gene expression data of cancerous and normal tissue through RNA - sequencing

    Measured: Range of 6 months to 5 years of patient recruitment

  2. Differential gene expression analysis in Gastric adenocarcinoma

    To determine differentially expressed gene between tumor and normal tissue through bioinformatic analysis of gene expression data

    Measured: Range of 6 months to 5 years of patient recruitment

  3. Influence of tumor microenvironment on gene expression profile of gastric adenocarcinoma

    To identify tumor microenvironment related genes and their functional annotation using bioinformatic packages

    Measured: Range of 6 months to 5 years of patient recruitment

  4. 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

    Measured: Range of 6 months to 5 years of patient recruitment

Secondary outcomes (1)

  1. 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

    Measured: Range of 6 months to 5 years of patient recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start6 Aug 2021
  3. Primary completion6 Apr 2025 (estimated)
  4. Study completion6 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
48 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05319392
Sponsor's protocol ID
2021-240-PhD-EXP-42
Acronym
GAC
Status last verified
Apr 2022
First submitted
31 Mar 2022
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30264431

  • 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.

    PubMed 32969836

  • 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.

    PubMed 32879664

  • 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.

    PubMed 33015704

  • 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.

    PubMed 32754268

  • 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.

    PubMed 29921304

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Adenocarcinoma, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Raghavendra Lingaiah (+91-522-2494250, raghulingaiah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcriptome profiling of Gastric adenocarcinoma (time frame: Range of 6 months to 5 years of patient recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05319392, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.

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