Bladder (Urothelial, Transitional Cell) CancerENPP1-BCNCT06657755
Evaluation of ENPP1 Expression and Immune Response in Bladder Cancer Patients
An observational study of Bladder (Urothelial, Transitional Cell) Cancer, run by Lanzhou University Second Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- Immunohistochemistry
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 20 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Immunohistochemistry
- Keywords
- ENPP1, bladder cancer, biomarker, prognosis, immune infiltration
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2024.1-2024.6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengyu You, Lanzhou University Second Hospital
- Investigators
- Zhilong Dong, MD, Study director, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657755
- Sponsor's protocol ID
- 2024A-948
- Other IDs
- D2024-686
- Acronym
- ENPP1-BC
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38498770Li 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.
PubMed 33372007Bageritz 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.
PubMed 24531536Sung 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.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate ENPP1 Expression and Its Role in Immune Evasion and Chemoresistance in Bladder Cancer
- ClinicalTrials.gov ID
- NCT06657755
- Acronym / sponsor ID
- ENPP1-BC / 2024A-948
- Keywords
- ENPP1, bladder cancer, biomarker, prognosis, immune infiltration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 24 Oct 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| ImmunohistochemistryThis 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. | Diagnostic test | – |
Primary outcome
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).
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 24 Oct 2024.
- Background: PubMed 38498770An 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.
- Background: PubMed 33372007Li 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.
- Background: PubMed 24531536Bageritz 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.
- Background: PubMed 33538338Sung 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.
- Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 CountriesLink provided by the sponsor.
- Stem cell characteristics in glioblastoma are maintained by the ecto-nucleotidase E-NPP1Link provided by the sponsor.
- Metastasis and Immune Evasion from Extracellular cGAMP HydrolysisLink provided by the sponsor.
- Tumor Exosomal ENPP1 Hydrolyzes cGAMP to Inhibit cGAS-STING SignalingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Zhilong Dong, MD study director
Lanzhou University Second 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 Bladder (Urothelial, Transitional Cell) Cancer, run by Lanzhou University Second 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 6 inclusion and 6 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 24 Oct 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?
ENPP1 Expression Levels in Bladder Cancer Patients (time frame: 2024.1-2024.6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657755, which also lists 4 linked publications.
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 24 Oct 2024.