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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Min NA Shi, MD; Phone Number: 021-25076143; Email: shimin@xinhuamed.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
      • Contact: Jie NA Ding, MD; Phone Number: 86-13564315425; Email: dingjie@xinhuamed.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients are in-hospital patients treated in Xinhua Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Renal cancer group; Patients which imaging studies have found renal mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.	Other: Blood test; About 4 ml of blood draw
Urothiasis group; Patients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100.	Other: Blood test; About 4 ml of blood draw
Renal cysts group; Patients which imaging studies have found renal cysts (simple or complex) about 100.	Other: Blood test; About 4 ml of blood draw
Liver cancer group; Patients which imaging studies have found hepatic mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100.	Other: Blood test; About 4 ml of blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: renal cancer; tumor biomarker
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: XHEC-C-2019-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to reveal IPD due to further research plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No