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

• Conditions: Carcinoma, Renal Cell
• Interventions: Other: Blood test

• Registration Number: NCT04113486
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-21
• Last Update Posted: 2020-11-24
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal cysts group	Blood test	Patients which imaging studies have found renal cysts (simple or complex) about 100.
Renal cancer group	Blood test	Patients which imaging studies have found renal mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.
Urothiasis group	Blood test	Patients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100.
Liver cancer group	Blood test	Patients which imaging studies have found hepatic mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.

Primary Outcome Measures

Name	Time	Method
NMAP level study	September 2019-September 2021	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.

Secondary Outcome Measures

Name	Time	Method
NMAP plus other tumor biomarkers study	September 2019-September 2021	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.

Trial Locations

Locations (1)

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China