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NCT Number: NCT05214885

Novel Biomarkers of Hypoxia and Metabolism in Clear Cell Renal Cell Carcinoma

Renal cell carcinoma (RCC) is one of the common malignant tumors in human beings and originates from the renal tubular epithelium. Clear cell renal cell carcinoma (ccRCC) is the main pathological type of RCC. Due to the lack of reliable biomarkers and clinical symptoms for early diagnosis, imaging findings such as ultrasound and CT are needed. When the patients presented typical symptoms, for example, hematuria, backache, and abdominal mass, some of them are in advanced stages of cancer. About a quarter of patients had metastasis at the first diagnosis, and the 5-year survival rate of these patients was less than 10%. Therefore, the early diagnosis of ccRCC and the prevention of tumor recurrence and metastasis are of great significance.

The preliminary studies suggested that some hypoxia and metabolism-related molecules were highly expressed in ccRCC tumors but low in normal kidney tissues. The molecules included carbonic anhydrase IX/9 (CA IX/CA9), the mitochondrial NADH dehydrogenase [ubiquinone] 1 alpha subcomplex, 4-like 2(NDUFA4L2), angiopoietin-like protein 4(ANGPTL4), hypoxia inducible lipid droplet-associated (HILPDA）, and egl-9 family hypoxia-inducible factor 3( EGLN3) et al . Cell-free DNA methylomes were also highly expressed in the blood of ccRCC patients.

In order to further verify the expression status of the above novel biomarkers in ccRCC, the investigators will detect the expressions of these molecules in the tumor and adjacent tissues from 140 ccRCC patients by RT-PCR, Western blot, and immunohistochemistry.140 healthy people were selected as the control group. 30 patients with benign kidney diseases were selected as another control group. Blood and urine samples from the ccRCC group and the control group were collected. The mRNA and protein levels of the above molecules in blood or urine samples were detected by qRT-PCR and ELISA. The correlation between the expression of the above new biomarkers and clinical data, such as early diagnosis, pathological grade, recurrence and metastasis, and survival time, was statistically analyzed. The above molecular changes were dynamically detected before surgery, 1 week, and 6 months after surgery. A receiver-operating characteristic curve (ROC) was used to determine the threshold value of these biomarkers for the diagnosis of renal clear cell carcinoma.

The study is to explore the specific tumor biomarker spectrum for clinical diagnosis, evaluation of recurrence, metastasis, and prognosis of ccRCC, which will be auxiliary early screening and diagnosis, reducing the harm of renal cancer to human health.

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Key information

Conditions

Clear Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, China

Location status: Recruiting

Location contact

li zhang, Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age and sex of the healthy control group were matched with that of ccRCC patient group. There was no tumor in the kidney or other parts of the body, and no tumor in the blood system. The healthy control group did not have any renal benign diseases, such as kidney stones, diabetic nephropathy, inflammation, and uremia. There are no inflammatory diseases in other parts of the body; the functions of the liver, kidney, and heart were normal.

Exclusion criteria

  • The volunteer has tumors in the kidney or other parts of the body, or blood system tumors; The volunteer has benign kidney diseases, such as kidney stones, diabetic nephropathy, nephritis and uremia, etc; The patient has inflammatory disease elsewhere. If the volunteer has any one of the above diseases, it shall be excluded.

Treatment and study plan

No intervention was required for patients or control group in this study

Diagnostic Test

The patient was treated normally and no intervention was required in this study

Primary outcomes

  1. Detection of novel biomarkers in ccRCC patients before surgery

    Time frame: For ccRCC patients, these six novel biomarkers were detected 1 to 3 days before surgery

    • The expressions of novel biomarkers in blood samples: The protein levels of CA9, NDUFA4L2, ANGPTL4, HILPDA and EGLN3 in blood samples were detected by ELISA method. The levels of cell-free DNA methylomes in blood samples were detected by real-time fluorescence quantitative PCR method.
    • The expressions of novel biomarkers in urine samples: The levels of cell-free DNA methylomes in urine samples were detected by real-time fluorescence quantitative PCR method.

  2. Detection of novel biomarkers in ccRCC patients 1 week after surgery

    Time frame: For ccRCC patients, the detection of these biomarkers were completed within one week after surgery

    • The expressions of novel biomarkers in tissues: In the tumor and adjacent tissues from ccRCC patients, the mRNA expressions of CA9, NDUFA4L2, ANGPTL4, HILPDA and EGLN3 were measured by real-time fluorescence quantitative PCR method. The protein expressions of these five molecules were detected by western blot, and immunohistochemistry methods.
    • The expressions of novel biomarkers in blood samples: The protein levels of CA9, NDUFA4L2, ANGPTL4, HILPDA and EGLN3 in blood samples were detected by ELISA method. The levels of cell-free DNA methylomes in blood samples were detected by real-time fluorescence quantitative PCR method.
    • The expressions of novel biomarkers in urine samples: The levels of cell-free DNA methylomes in urine samples were detected by real-time fluorescence quantitative PCR method.

  3. Detection of novel biomarkers in ccRCC patients at 6 months after surgery

    Time frame: For ccRCC patients, these six novel biomarkers were detected at 6 months postoperatively

    • The expressions of novel biomarkers in blood samples: The protein levels of CA9, NDUFA4L2, ANGPTL4, HILPDA and EGLN3 in blood samples were detected by ELISA method. The levels of cell-free DNA methylomes in blood samples were detected by real-time fluorescence quantitative PCR method.
    • The expressions of novel biomarkers in urine samples: The levels of cell-free DNA methylomes in urine samples were detected by real-time fluorescence quantitative PCR method.

  4. Detection of novel biomarkers in the control groups as baseline

    Time frame: For the healthy control group and the benign kidney disease group, the levels of these six biomarkers were detected as baseline.

    • The expressions of novel biomarkers in blood samples: The protein levels of CA9, NDUFA4L2, ANGPTL4, HILPDA and EGLN3 in blood samples were detected by ELISA method. The levels of cell-free DNA methylomes in blood samples were detected by real-time fluorescence quantitative PCR method.
    • The expressions of novel biomarkers in urine samples: The levels of cell-free DNA methylomes in urine samples were detected by real-time fluorescence quantitative PCR method.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zhang, Dr.

CONTACT

[email protected]

+86-531-89269680

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2022
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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