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

NCT04113486 | Unknown

• 1 other identifier: XHEC-C-2019-104
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

renal cancer; tumor biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NMAP plus other tumor biomarkers study

  September 2019-September 2021

Study Arms (4)

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

Urothiasis group

Patients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100.

Other: Blood test

Renal cysts group

Patients which imaging studies have found renal cysts (simple or complex) about 100.

Other: Blood test

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

Interventions

Blood test OTHER

About 4 ml of blood draw

Liver cancer group; Renal cancer group; Renal cysts group; Urothiasis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients are in-hospital patients treated in Xinhua Hospital

You may qualify if:

• 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
• Age ≥ 18 years old and able to provide written informed consent;
• Have not received any systemic or topical treatment for kidney/liver tumors.
• Cardiopulmonary, liver and kidney functions are able to tolerate surgery and can comply with research requirements.

You may not qualify if:

• The subjects is known or suspected of other malignancies.
• There has been another history of malignancy in the past 5 years.
• Major surgery (surgery requiring general anesthesia) was performed within 4 weeks prior to screening visits.

Sponsors & Collaborators

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

Study Sites (1)

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Min NA Shi, MD

CONTACT

021-25076143; shimin@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: October 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)