Evaluation of ENPP1 Expression and Immune Response in Bladder Cancer Patients (ENPP1-BC)

October 23, 2024 updated by: Chengyu You, Lanzhou University Second Hospital

A Study to Evaluate ENPP1 Expression and Its Role in Immune Evasion and Chemoresistance in Bladder Cancer

This study aims to investigate the role of ENPP1 in bladder cancer (BC), specifically focusing on its impact on immune evasion, chemoresistance, and prognosis. The study will analyze gene expression data from clinical samples and use various laboratory techniques, including RNA sequencing, qRT-PCR, and immunohistochemistry, to assess ENPP1's expression levels. In addition, the research will explore the relationship between ENPP1 and immune cell infiltration, along with its correlation with patient survival outcomes. By identifying ENPP1's contribution to cancer progression and treatment resistance, the study aims to discover potential therapeutic targets for improving bladder cancer treatment strategies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to comprehensively explore the role of ENPP1 (Ectonucleotide Pyrophosphatase/Phosphodiesterase 1) in bladder cancer (BC) development and progression. ENPP1 has been implicated in various cancers, with evidence suggesting its involvement in immune evasion, chemoresistance, and poor prognosis. However, its specific function in bladder cancer remains unclear. This research will analyze clinical samples, including tumor tissues and normal adjacent tissues, to evaluate ENPP1 expression through a combination of advanced laboratory techniques such as RNA sequencing, quantitative real-time PCR (qRT-PCR), Western blotting, immunohistochemistry (IHC), and immunofluorescence.

Furthermore, the study will investigate the association between ENPP1 expression and key clinical parameters, including tumor stage, grade, lymph node involvement, metastasis, and patient survival outcomes. Through bioinformatics tools, immune infiltration analysis will be conducted to assess the impact of ENPP1 on immune cells such as CD8+ T cells, dendritic cells, and M2 macrophages, which are crucial in the tumor microenvironment.

The research will also explore the correlation between ENPP1 expression and resistance to common chemotherapeutic agents, particularly gemcitabine and cytarabine, using drug sensitivity data from public databases. By identifying the molecular mechanisms by which ENPP1 influences immune responses and chemoresistance, the study aims to provide valuable insights into potential therapeutic targets for bladder cancer treatment. Ultimately, this research may contribute to the development of personalized therapies for bladder cancer patients based on ENPP1 expression.

Study Type

Observational

Enrollment (Actual)

12

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

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Lanzhou University Second Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adult patients aged 18 years or older with a confirmed diagnosis of bladder cancer. Participants will be recruited from oncology clinics and hospitals, and all eligible individuals must have measurable disease as defined by RECIST criteria. Both male and female participants will be included, with no restrictions based on ethnicity or socioeconomic background. Participants will be required to provide informed consent and meet the inclusion criteria related to health status and prior treatments.

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Histologically confirmed diagnosis of bladder cancer.
  • Measurable disease as per RECIST criteria.
  • Adequate organ function as defined by laboratory tests (e.g., liver, kidney, and hematologic function).
  • ENPP1 expression level determined via biopsy or previous analysis.
  • Written informed consent provided.

Exclusion Criteria:

  • History of other malignancies within the past 5 years, excluding non-melanoma skin cancer or in situ carcinoma.
  • Prior treatment with ENPP1 inhibitors or similar targeted therapies.
  • Active or uncontrolled infections.
  • Pregnant or breastfeeding women.
  • Known autoimmune disorders or conditions requiring immunosuppressive therapy.
  • Inability to comply with the study protocol or procedures.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ENPP1 Expression Levels in Bladder Cancer Patients
Time Frame: 2024.1-2024.6
The primary outcome will measure the expression levels of ENPP1 in bladder cancer tissues compared to adjacent normal tissues, and its correlation with clinical outcomes such as overall survival (OS) and progression-free survival (PFS).
2024.1-2024.6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lanzhou University Second Hospital

Investigators

  • Study Director: Zhilong Dong, MD, Lanzhou University Second Hospital

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

Helpful Links

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)

June 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024A-948
  • D2024-686 (Other Identifier: Lanzhou University Second Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data (IPD) with other researchers due to the sensitive nature of the clinical data involved. However, aggregated data and relevant findings from the study will be published in peer-reviewed journals to contribute to the scientific community.

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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