DiagnosisNCT06392750
PWP1's Expression in Gastric Cancer.
An observational study of Diagnosis and Gastric Cancer, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diagnosis, Gastric Cancer
- What is being tested?
- Collection of tumor tissue specimens
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 200 gastric cancer patients, including 80 (40.0%) men and 120(60.0%) women, were enrolled in this study.
Who may be able to join
- Diagnosed as gastric cancer
- Performing gastric cancer resection surgery
- Informed consent signed prior to surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou
Yangzhou, Jiangsu, 225001
About this study
Official title: PWP1 Affects Gastric Cancer Progression by Regulating p53 and JAK1 and Its Expression in Gastric Cancer.
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.
- Conditions
- Diagnosis, Gastric Cancer
- Being tested
- Collection of tumor tissue specimens
- Keywords
- gastric cancer, PWP1, IHC, expression
- Medical subject headings
- Disease, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of tumor tissue specimensBehavioural
Collection of tumor tissue specimens during surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collection of tumor tissue specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 May 2021
- Primary completion30 Oct 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daorong Wang, Northern Jiangsu People's Hospital
- Investigators
- Daorong Wang, M.D., Professor, Study director, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392750
- Sponsor's protocol ID
- mj2404001
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contains a large amount of personal information about patients and needs to be treated with caution.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PWP1 Affects Gastric Cancer Progression by Regulating p53 and JAK1 and Its Expression in Gastric Cancer.
- ClinicalTrials.gov ID
- NCT06392750
- Acronym / sponsor ID
- mj2404001
- Conditions
- Diagnosis, Gastric Cancer
- Keywords
- gastric cancer, PWP1, IHC, expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Behavioral: Collection of tumor tissue specimensParaffin tissue microarray slides prepared from tumor tissue removed during gastrectomy were retrieved from the biological sample library of the Northern Jiangsu People's Hospital. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 200 gastric cancer patients, including 80 (40.0%) men and 120(60.0%) women, were enrolled in this study.
Key inclusion criteria (3 listed)
- Diagnosed as gastric cancer
- Performing gastric cancer resection surgery
- Informed consent signed prior to surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of tumor tissue specimensCollection of tumor tissue specimens during surgery | Behavioural | tumor tissues |
Primary outcome
The expression of PWP1 in adjacent tissues and tumor tissues of patients with gastrectomy for gastric cancer.
Time frame: 6 to 12 months after operation
Test the expression of PWP1 in adjacent tissues and tumor tissues of patients with gastrectomy for gastric cancer through the immunohistochemical.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided. Contains a large amount of personal information about patients and needs to be treated with caution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daorong Wang, M.D., Professor study director
Northern Jiangsu People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis and Gastric Cancer, run by Northern Jiangsu People's Hospital at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression of PWP1 in adjacent tissues and tumor tissues of patients with gastrectomy for gastric cancer. (time frame: 6 to 12 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2024.