Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05214885
Status:
RECRUITING
Last Update Posted:
2022-03-09
First Post:
2022-01-05
Brief Title:
Novel Biomarkers of Hypoxia and Metabolism in Clear Cell Renal Cell Carcinoma
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Novel Biomarkers of Hypoxia and Metabolism in Clear Cell Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IX9 CA IXCA9 the mitochondrial NADH dehydrogenase ubiquinone 1 alpha subcomplex 4-like 2NDUFA4L2 angiopoietin-like protein 4ANGPTL4 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 immunohistochemistry140 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
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 IX9 CA IXCA9 the mitochondrial NADH dehydrogenase ubiquinone 1 alpha subcomplex 4-like 2NDUFA4L2 angiopoietin-like protein 4ANGPTL4 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 immunohistochemistry140 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None