Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations

Carcinoma, Renal Cell Clinical Trial

— ENRC  

Official title:

Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113486
• Other study ID #: XHEC-C-2019-104
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Min NA Shi, MD
• Phone: 021-25076143
• Email: shimin[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to observe the difference between NMAP (nicotinamide metabolism associated protein) serum levels in primary diagnosed renal cancer patients and non-renal cancer patient controls, plot the ROC curve and establish appropriate cut-off values.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The tumor group patients were found to have renal or hepatic mass, plan to receive surgical treatment (except for radiofrequency ablation, cryoablation, etc., which were not available for pathological examination). The control group patients were ruled out of tumor based on radiological tests and commonly used tumor biomarkers

2. Age = 18 years old and able to provide written informed consent;

3. Have not received any systemic or topical treatment for kidney/liver tumors.

4. Cardiopulmonary, liver and kidney functions are able to tolerate surgery and can comply with research requirements.

Exclusion Criteria:

1. The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.

2. The subjects is known or suspected of other malignancies.

3. There has been another history of malignancy in the past 5 years.

4. Major surgery (surgery requiring general anesthesia) was performed within 4 weeks prior to screening visits.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms

Intervention

Other:
• Blood test
About 4 ml of blood draw

Locations

Country	Name	City	State
China	Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NMAP level study	To observe the difference in the expression level of nicotinamide metabolism related protein (NMAP) in the serum of newly diagnosed renal cancer and non-renal cancer patients. Draw the NMAP ROC curve and establish the appropriate Cut-off value to analyze its sensitivity and specificity.	September 2019-September 2021
Secondary	NMAP plus other tumor biomarkers study	According to NMAP and combined with other tumor biomarkers data such as AFP, multiple regression analysis was used to map the ROC curve and establish the appropriate Cut-off value to determine whether it is capable of distinguishing kidney cancer and liver cancer.	September 2019-September 2021