NCT06778538

Brief Summary

This study aims to investigate the role of HPGD in clear cell renal cell carcinoma (ccRCC). Specifically, it will focus on HPGD's impact on proliferation, epithelial-mesenchymal transition (EMT), and prognosis. The study will analyze gene expression data from clinical samples and use techniques like RT-qPCR, Western blotting, and immunohistochemistry to assess HPGD expression levels. Additionally, the research will explore the relationship between HPGD and patient survival outcomes. By elucidating HPGD's contribution to cancer progression, the study seeks to identify potential therapeutic targets for improving renal cancer treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 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

July 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 11, 2025

Last Update Submit

January 11, 2025

Conditions

Keywords

HPGDclear cell renal cell carcinomabiomarkerprognosisEMTtumorigenesisSLCO2A1

Outcome Measures

Primary Outcomes (1)

  • HPGD Expression Levels in clear cell renal cell carcinoma(ccRCC) Patients

    The primary outcome will measure the expression levels of HPGD in ccRCC 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

The intervention will specifically focus on evaluating the role of HPGD in patients with clear cell renal cell carcinoma by classifying them into high-low expression groups based on median HPGD expression values by immunohistochemical scores for prognostic analysis. Protein and RNA were extracted from collected ccRCC tissues for expression verification.

Eligibility Criteria

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

The study population will consist of adult patients aged 18 years or older with a confirmed diagnosis of clear cell renal cell carcinoma. 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 clear cell renal cell carcinoma . Measurable disease as per RECIST criteria. Adequate organ function as defined by laboratory tests (e.g., liver, kidney, and hematologic function).
  • HPGD 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 HPGD 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou University Second Hospital

Lanzhou, Gansu, 730000, China

Location

Related Publications (4)

  • Monteleone NJ, Moore AE, Iacona JR, Lutz CS, Dixon DA. miR-21-mediated regulation of 15-hydroxyprostaglandin dehydrogenase in colon cancer. Sci Rep. 2019 Apr 1;9(1):5405. doi: 10.1038/s41598-019-41862-2.

    PMID: 30931980BACKGROUND
  • Arima K, Komohara Y, Bu L, Tsukamoto M, Itoyama R, Miyake K, Uchihara T, Ogata Y, Nakagawa S, Okabe H, Imai K, Hashimoto D, Chikamoto A, Yamashita YI, Baba H, Ishimoto T. Downregulation of 15-hydroxyprostaglandin dehydrogenase by interleukin-1beta from activated macrophages leads to poor prognosis in pancreatic cancer. Cancer Sci. 2018 Feb;109(2):462-470. doi: 10.1111/cas.13467. Epub 2018 Jan 27.

    PMID: 29224225BACKGROUND
  • Myung SJ, Rerko RM, Yan M, Platzer P, Guda K, Dotson A, Lawrence E, Dannenberg AJ, Lovgren AK, Luo G, Pretlow TP, Newman RA, Willis J, Dawson D, Markowitz SD. 15-Hydroxyprostaglandin dehydrogenase is an in vivo suppressor of colon tumorigenesis. Proc Natl Acad Sci U S A. 2006 Aug 8;103(32):12098-102. doi: 10.1073/pnas.0603235103. Epub 2006 Jul 31.

    PMID: 16880406BACKGROUND
  • Wolf I, O'Kelly J, Rubinek T, Tong M, Nguyen A, Lin BT, Tai HH, Karlan BY, Koeffler HP. 15-hydroxyprostaglandin dehydrogenase is a tumor suppressor of human breast cancer. Cancer Res. 2006 Aug 1;66(15):7818-23. doi: 10.1158/0008-5472.CAN-05-4368.

    PMID: 16885386BACKGROUND

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

Carcinoma, Renal CellCarcinogenesis

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 16, 2025

Study Start

July 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 20, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations