NCT06392750

Brief Summary

Background:Gastric cancer is a globally important disease and the fifth most diagnosed malignant cancer in the world. Because it is usually diagnosed at an advanced stage, gastric cancer has a high mortality rate, making it the third most common cause of cancer-related death. Hot spots of gastric cancer incidence and mortality exist in East Asia, Eastern Europe and South America. It is still an urgent problem to find new diagnostic and prognostic markers and better understand the molecular mechanism of gastric cancer. Although radical resection and systemic chemotherapy have shown great improvement, the prognosis of gastric cancer (GC) patients is still depressing due to malignant proliferation and metastasis. Therefore, it is urgent to clarify the potential molecular mechanism of gastric cancer progression, which will contribute to the development of targeted therapy. Effective induction of tumor cell apoptosis is the most important feature of a new chemical agent for cancer treatment. There is increasing evidence that the cell cycle can act in concert with apoptosis to cause cell death under certain cellular stress conditions. A comprehensive understanding of the relationship between apoptosis and cell cycle is essential for developing effective cancer therapies. PWP1 is also known as endonuclein, which contains five WD40 repeated domains and belongs to the WD40-repeated superfamily. It is highly expressed in human pancreatic adenocarcinoma, where it functions as a cell-cycle regulator. However, the normal function of Pwp1 is largely unknown. Previous research data show that PWP1 plays a key role in regulating biological functions such as RNA processing, signal transduction, gene expression, vesicle transport, cytoskeleton assembly and cell cycle progression. Whether the high expression of PWP1 is ubiquitous in tumors, the relationship between the high expression and clinicopathological factors of tumors, and the mechanism of PWP1 in tumors are still unclear. Further exploration of the molecular mechanism of PWP1 in GC may provide new ideas and therapeutic targets for GC treatment in the future, and benefit clinical patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

April 26, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

gastric cancerPWP1IHCexpression

Outcome Measures

Primary Outcomes (1)

  • The expression of PWP1 in adjacent tissues and tumor tissues of patients with gastrectomy for gastric cancer.

    Test the expression of PWP1 in adjacent tissues and tumor tissues of patients with gastrectomy for gastric cancer through the immunohistochemical.

    6 to 12 months after operation

Study Arms (2)

adjacent tissues

Paraffin tissue microarray slides prepared from normal tissue adjacent to tumor tissue removed during gastrectomy were retrieved from the biological sample library of the Northern Jiangsu People's Hospital.

tumor tissues

Paraffin tissue microarray slides prepared from tumor tissue removed during gastrectomy were retrieved from the biological sample library of the Northern Jiangsu People's Hospital.

Behavioral: Collection of tumor tissue specimens

Interventions

Collection of tumor tissue specimens during surgery

tumor tissues

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 200 gastric cancer patients, including 80 (40.0%) men and 120(60.0%) women, were enrolled in this study.

You may qualify if:

  • Diagnosed as gastric cancer
  • Performing gastric cancer resection surgery
  • Informed consent signed prior to surgery.

You may not qualify if:

  • Emergency surgery
  • Preoperative and intraoperative detection of distant organ metastases or extensive
  • No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
  • Incomplete case data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou

Yangzhou, Jiangsu, 225001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Apply to the biological sample library for samples of tumor tissue and adjacent tissues preserved during surgery in gastric cancer patients. Subsequently, prepare tissue slices for immunohistochemical staining and compare the expression profiles between the two sample groups.

MeSH Terms

Conditions

DiseaseStomach Neoplasms

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Daorong Wang, M.D., Professor

    Northern Jiangsu People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D.

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

May 1, 2021

Primary Completion

October 30, 2023

Study Completion

April 1, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations