Evaluation of ENPP1 Expression and Immune Response in Bladder Cancer Patients

NCT06657755 | Completed

• 2 other identifiers: 2024A-948D2024-686
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Keywords

ENPP1; bladder cancer; biomarker; prognosis; immune infiltration

Outcome Measures

Primary Outcomes (1)

• ENPP1 Expression Levels in Bladder Cancer Patients

  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

Interventions

Immunohistochemistry DIAGNOSTIC_TEST

This intervention will specifically focus on evaluating the role of ENPP1 in bladder cancer patients, distinguishing it from other interventions by targeting immune evasion and chemoresistance pathways. The intervention will include a combination of targeted molecular therapies and immunotherapy, aimed at assessing the therapeutic potential of ENPP1 inhibition in improving treatment outcomes for bladder cancer patients. This differs from previous studies by integrating advanced biomarker analysis and personalized treatment approaches based on ENPP1 expression levels.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lanzhou University Second Hospital: lead

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730000, China

Location

Related Publications (4)

• An Y, Zhu J, Xie Q, Feng J, Gong Y, Fan Q, Cao J, Huang Z, Shi W, Lin Q, Wu L, Yang C, Ji T. Tumor Exosomal ENPP1 Hydrolyzes cGAMP to Inhibit cGAS-STING Signaling. Adv Sci (Weinh). 2024 May;11(20):e2308131. doi: 10.1002/advs.202308131. Epub 2024 Mar 18.

  PMID: 38498770 BACKGROUND

• Li J, Duran MA, Dhanota N, Chatila WK, Bettigole SE, Kwon J, Sriram RK, Humphries MP, Salto-Tellez M, James JA, Hanna MG, Melms JC, Vallabhaneni S, Litchfield K, Usaite I, Biswas D, Bareja R, Li HW, Martin ML, Dorsaint P, Cavallo JA, Li P, Pauli C, Gottesdiener L, DiPardo BJ, Hollmann TJ, Merghoub T, Wen HY, Reis-Filho JS, Riaz N, Su SM, Kalbasi A, Vasan N, Powell SN, Wolchok JD, Elemento O, Swanton C, Shoushtari AN, Parkes EE, Izar B, Bakhoum SF. Metastasis and Immune Evasion from Extracellular cGAMP Hydrolysis. Cancer Discov. 2021 May;11(5):1212-1227. doi: 10.1158/2159-8290.CD-20-0387. Epub 2020 Dec 28.

  PMID: 33372007 BACKGROUND

• Bageritz J, Puccio L, Piro RM, Hovestadt V, Phillips E, Pankert T, Lohr J, Herold-Mende C, Lichter P, Goidts V. Stem cell characteristics in glioblastoma are maintained by the ecto-nucleotidase E-NPP1. Cell Death Differ. 2014 Jun;21(6):929-40. doi: 10.1038/cdd.2014.12. Epub 2014 Feb 14.

  PMID: 24531536 BACKGROUND

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

  PMID: 33538338 BACKGROUND

Related Links

• Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries
• Stem cell characteristics in glioblastoma are maintained by the ecto-nucleotidase E-NPP1
• Metastasis and Immune Evasion from Extracellular cGAMP Hydrolysis
• Tumor Exosomal ENPP1 Hydrolyzes cGAMP to Inhibit cGAS-STING Signaling

Biospecimen

Retention: SAMPLES WITH DNA

Tissue samples, blood samples, and other relevant biological specimens will be retained for future analysis, including potential DNA extraction for genetic studies.

MeSH Terms

Conditions

Neoplasms; Urinary Bladder Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Zhilong Dong, MD

  Lanzhou University Second Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lanzhou University Second Hospital

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 20, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)