NCT05985577

Brief Summary

Gastric signet ring cell carcinoma (GSRCC) possesses unique epidemiology and pathogenesis in the field of cancer, but its incidence is low. Unfortunately, there is currently a lack of systematic research focusing on the prognostic proteomic features of GSRCC. Given this knowledge gap, this study aims to comprehensively characterize the proteomic landscape of GSRCC using a reliable and reproducible DIA-PCT method. This study objectives include characterizing the heterogeneity of GSRCC, performing molecular typing, identifying potential biomarkers and therapeutic targets, and providing a resource for stratified analysis of GSRCC. To achieve these goals, the investigators selected a cohort of 112 GSRCC patients from a pool of over 10,000 gastric cancer patients and conducted a proteomic analysis using the DIA-PCT method. This meticulous approach revealed four novel proteomic subtypes of GSRCC, each exhibiting unique molecular characteristics. Additionally, the investigators discovered that PRDX2 and DDX27 can serve as predictive biomarkers for GSRCC, which were further validated in an independent cohort of 75 GSRCC patients. Furthermore, the investigators paid particular attention to the MLT-GSRCC subgroup and identified three distinct proteomic clusters among MLT-GSRCC patients. Subtype 2 within this subgroup demonstrated the poorest prognosis. Through a rigorous screening process, the investigators determined potential targets for the treatment of GSRCC. In conclusion, these findings contribute to the investigators understanding of the heterogeneity of GSRCC and provide valuable resources for future clinical stratification and targeted treatment strategies.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

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

March 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

July 17, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

Gastric signet ring cell carcinomaMolecular SubtypesProteomicsPrognostic markersDrug target

Outcome Measures

Primary Outcomes (1)

  • The proteome of tissue

    The samples diagnosed as GSRCC by pathology were selected as the samples with signet ring cell content \> 70% as judged by 2 pathologists of associate chief physician or above and without previous radiotherapy and chemotherapy. Tumor tissues and paired nat were collected from the same patient at the time of tumor resection and stored in formalin-fixed paraffin embedding (FFPE). Liquid chromatography-mass spectrometry (LC-MS) was used to detect the proteomics in the samples. The proteins in the samples were extracted, and the proteomics in the samples was detected by LC-MS. Qualitative and quantitative analysis was performed to detect the types and content of proteins in the samples.

    Lc-MS/MS was used to detect the types of proteins in the samples and the relative amounts in the samples compared with Normal adjacent tissue, an average of one month

Study Arms (2)

Cancer tissues

Cancer tissues

Other: Without any intervention

Normal adjacent tissues

Normal adjacent tissues

Other: Without any intervention

Interventions

There were no special interventions for the two groups.

Cancer tissuesNormal adjacent tissues

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

These cases had a signet ring cell content greater than 70% and had not undergone prior chemotherapy or radiotherapy

You may qualify if:

  • confirmed GSRCC by pathology, where GSRCC is defined as having a percentage of signet ring cell ≥ 50%
  • patients with complete medical information
  • patients with survival follow-up information

You may not qualify if:

  • patients with other malignant tumors
  • presence of other pathological components (e.g., neuroendocrine carcinoma and squamous cell carcinoma, etc)
  • incomplete or lost case information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (5)

  • Puccini A, Poorman K, Catalano F, Seeber A, Goldberg RM, Salem ME, Shields AF, Berger MD, Battaglin F, Tokunaga R, Naseem M, Zhang W, Philip PA, Marshall JL, Korn WM, Lenz HJ. Molecular profiling of signet-ring-cell carcinoma (SRCC) from the stomach and colon reveals potential new therapeutic targets. Oncogene. 2022 Jun;41(26):3455-3460. doi: 10.1038/s41388-022-02350-6. Epub 2022 May 26.

  • Fan Y, Bai B, Liang Y, Ren Y, Liu Y, Zhou F, Lou X, Zi J, Hou G, Chen F, Zhao Q, Liu S. Proteomic Profiling of Gastric Signet Ring Cell Carcinoma Tissues Reveals Characteristic Changes of the Complement Cascade Pathway. Mol Cell Proteomics. 2021;20:100068. doi: 10.1016/j.mcpro.2021.100068. Epub 2021 Mar 3.

  • Ge S, Xia X, Ding C, Zhen B, Zhou Q, Feng J, Yuan J, Chen R, Li Y, Ge Z, Ji J, Zhang L, Wang J, Li Z, Lai Y, Hu Y, Li Y, Li Y, Gao J, Chen L, Xu J, Zhang C, Jung SY, Choi JM, Jain A, Liu M, Song L, Liu W, Guo G, Gong T, Huang Y, Qiu Y, Huang W, Shi T, Zhu W, Wang Y, He F, Shen L, Qin J. A proteomic landscape of diffuse-type gastric cancer. Nat Commun. 2018 Mar 8;9(1):1012. doi: 10.1038/s41467-018-03121-2.

  • Asleh K, Negri GL, Spencer Miko SE, Colborne S, Hughes CS, Wang XQ, Gao D, Gilks CB, Chia SKL, Nielsen TO, Morin GB. Proteomic analysis of archival breast cancer clinical specimens identifies biological subtypes with distinct survival outcomes. Nat Commun. 2022 Feb 16;13(1):896. doi: 10.1038/s41467-022-28524-0.

  • Chen J, Liu K, Luo Y, Kang M, Wang J, Chen G, Qi J, Wu W, Wang B, Han Y, Shi L, Wang K, Han X, Ma X, Liu W, Ding Y, Wang L, Liang H, Wang L, Chen J. Single-Cell Profiling of Tumor Immune Microenvironment Reveals Immune Irresponsiveness in Gastric Signet-Ring Cell Carcinoma. Gastroenterology. 2023 Jul;165(1):88-103. doi: 10.1053/j.gastro.2023.03.008. Epub 2023 Mar 14.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples are used for proteomic analysis.

MeSH Terms

Conditions

Stomach NeoplasmsCarcinoma, Signet Ring Cell

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Cystic, Mucinous, and Serous

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Secretary of the party committee

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 14, 2023

Study Start

March 2, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.

Locations