- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985577
Mechanism of Gastric Signet Ring Cell Carcinoma Based on Microproteomics
August 2, 2023 updated by: Xiangdong Cheng, Zhejiang Cancer Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
These cases had a signet ring cell content greater than 70% and had not undergone prior chemotherapy or radiotherapy
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients with other malignant tumors
- presence of other pathological components (e.g., neuroendocrine carcinoma and squamous cell carcinoma, etc)
- incomplete or lost case information
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer tissues
|
There were no special interventions for the two groups.
|
|
Normal adjacent tissues
|
There were no special interventions for the two groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proteome of tissue
Time Frame: 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
|
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.
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Nat Commun. 2018 May 8;9(1):1850.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
July 17, 2023
First Submitted That Met QC Criteria
August 2, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2023-584
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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