Carcinoma, Renal CellENRCNCT04113486
Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations
An observational study of Carcinoma, Renal Cell, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Blood test
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients are in-hospital patients treated in Xinhua Hospital
Who may be able to join
- 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.
Who cannot join
- The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jie NA Ding, MD, 86-13564315425, dingjie@xinhuamed.com.cn
About this study
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
- Being tested
- Blood test
- Keywords
- renal cancer, tumor biomarker
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
About 4 ml of blood draw
| Study group | Role | What they receive |
|---|---|---|
| Renal cancer group | Patients which imaging studies have found renal mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100. Receives: Other: Blood test | |
| Urothiasis group | Patients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100. Receives: Other: Blood test | |
| Renal cysts group | Patients which imaging studies have found renal cysts (simple or complex) about 100. Receives: 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. Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: September 2019-September 2021
Secondary outcomes (1)
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.
Measured: September 2019-September 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Oct 2019
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ding, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113486
- Sponsor's protocol ID
- XHEC-C-2019-104
- Acronym
- ENRC
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 2019
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to reveal IPD due to further research plan
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Levels of Nicotinamide Metabolism-related Protein (NMAP) in Newly Diagnosed Renal Cancer and Non-renal Cancer Populations
- ClinicalTrials.gov ID
- NCT04113486
- Acronym / sponsor ID
- ENRC / XHEC-C-2019-104
- Conditions
- Carcinoma, Renal Cell
- Keywords
- renal cancer, tumor biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Renal cancer group | – | Other: Blood testPatients which imaging studies have found renal mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100. |
| Urothiasis group | – | Other: Blood testPatients which imaging studies have found renal or ureteral stones, and rule out of renal mass, about 100. |
| Renal cysts group | – | Other: Blood testPatients which imaging studies have found renal cysts (simple or complex) about 100. |
| Liver cancer group | – | Other: Blood testPatients which imaging studies have found hepatic mass, plan to receive surgery (except for radiofrequency ablation, cryoablation, etc.), about 100. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients are in-hospital patients treated in Xinhua Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- The investigators believe that the subject may be unsuitable for inclusion due to severe concurrent diseases, infections, and etc.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAbout 4 ml of blood draw | Other | Liver cancer group, Renal cancer group, Renal cysts group, Urothiasis group |
Primary outcome
NMAP level study
Time frame: 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.
1 secondary outcome
NMAP plus other tumor biomarkers study
Time frame: September 2019-September 2021
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. No plan to reveal IPD due to further research plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min NA Shi, MD (021-25076143, shimin@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMAP level study (time frame: September 2019-September 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.