Renal CarcinomaNCT06917560
Serological Autoantibodies in Early Kidney Cancer Diagnosis and Prognosis: A Multicenter Study
An observational study of Renal Carcinoma and Serology, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This project aims to construct a multicenter retrospective study by retrospectively collecting clinical, serological, and pathological data from patients. A comprehensive data management system will be established to facilitate the integration and analysis of multicenter data, alongside antibody profiling… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Renal Carcinoma, Serology, Autoantibody
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Aug 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with histologically confirmed renal cell carcinoma
Who may be able to join
- Pathological diagnosis of ccRCC;
- Availability of complete clinical, pathological, and follow-up data;
- Sufficient preoperative serum available for collection;
- Well-preserved pathological slides for subsequent immunohistochemical (chip) analysis;
- At least one post-treatment follow-up/efficacy evaluation.
Who cannot join
- Therapeutic contraindication cohort: Individuals presenting with severe comorbidities rendering them medically ineligible for therapeutic interventions;
- Oncological multiplicity: Subjects with either (a) antecedent therapeutic regimens targeting non-index malignancies or (b) concurrent diagnosis of untreated active malignancies;
- Biospecimen integrity violation: Cases demonstrating serum hemolysis or compromised specimen integrity;
- Data insufficiency cohort: Patients exhibiting incomplete clinical/pathological records or insufficient longitudinal follow-up data for comprehensive analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
first hospital affiliated of Fujian medical university
Fuzhou, Fujian, 350005
About this study
Official title: The Role of Serological Autoantibody Profiles in the Early Diagnosis and Prognosis of Renal Carcinoma: A Multicenter, Retrospective Clinical Study
This project aims to construct a multicenter retrospective study by retrospectively collecting clinical, serological, and pathological data from patients. A comprehensive data management system will be established to facilitate the integration and analysis of multicenter data, alongside antibody profiling characteristics. A predictive model based on serological autoantibody profiles will be developed and validated using both internal and external cohorts. This model will predict clinical prognostic factors in renal carcinoma and identify patient populations likely to respond to immunotherapy. By enabling personalized treatment decisions and minimizing unnecessary treatment risks, the model aims to improve patient quality of life and overall prognosis.
- Conditions
- Renal Carcinoma, Serology, Autoantibody
- Keywords
- Renal Carcinoma, Autoantibody, serology
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
serum autoantibodies
After incubating the serum on the HuProt array, autoantibody signals were detected, standardized, and quantified. For the selection of candidate proteins, three criteria must be met when comparing ccRCC with healthy controls: (1) a p-value ≤ 0.05 obtained from the t-test; (2) a fold change (FC) ≥ 1.2; (3) a positivity rate ≥ 10% (ccRCC positive reactivity is defined as values greater than the average of the healthy control group plus 2× SD. The positivity rate is calculated as the ratio of ccRCC positive responses to the total number of responses).
Measured: Prior to any treatment or surgery, 5 mL of venous blood was collected from each individual and allowed to stand at room temperature (RT) for 1 hour to facilitate coagulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917560
- Sponsor's protocol ID
- MRCTA,ECFAH OfFMUI2024]697
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serological Autoantibody Profiles in the Early Diagnosis and Prognosis of Renal Carcinoma: A Multicenter, Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT06917560
- Acronym / sponsor ID
- MRCTA,ECFAH OfFMUI2024]697
- Conditions
- Renal Carcinoma, Serology, Autoantibody
- Keywords
- Renal Carcinoma, Autoantibody, serology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, The First Affiliated Hospital of Xiamen University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Apr 2025 (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 project aims to construct a multicenter retrospective study by retrospectively collecting clinical, serological, and pathological data from patients. A comprehensive data management system will be established to facilitate the integration and analysis of multicenter data, alongside antibody profiling characteristics. A predictive model based on serological autoantibody profiles will be developed and validated using both internal and external cohorts. This model will predict clinical prognostic factors in renal carcinoma and identify patient populations likely to respond to immunotherapy. By enabling personalized treatment decisions and minimizing unnecessary treatment risks, the model aims to improve patient quality of life and overall prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with histologically confirmed renal cell carcinoma
Key inclusion criteria (5 listed)
- Pathological diagnosis of ccRCC;
- Availability of complete clinical, pathological, and follow-up data;
- Sufficient preoperative serum available for collection;
- Well-preserved pathological slides for subsequent immunohistochemical (chip) analysis;
- At least one post-treatment follow-up/efficacy evaluation.
Key exclusion criteria (4 listed)
- Therapeutic contraindication cohort: Individuals presenting with severe comorbidities rendering them medically ineligible for therapeutic interventions;
- Oncological multiplicity: Subjects with either (a) antecedent therapeutic regimens targeting non-index malignancies or (b) concurrent diagnosis of untreated active malignancies;
- Biospecimen integrity violation: Cases demonstrating serum hemolysis or compromised specimen integrity;
- Data insufficiency cohort: Patients exhibiting incomplete clinical/pathological records or insufficient longitudinal follow-up data for comprehensive analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum autoantibodies
Time frame: Prior to any treatment or surgery, 5 mL of venous blood was collected from each individual and allowed to stand at room temperature (RT) for 1 hour to facilitate coagulation.
After incubating the serum on the HuProt array, autoantibody signals were detected, standardized, and quantified. For the selection of candidate proteins, three criteria must be met when comparing ccRCC with healthy controls: (1) a p-value ≤ 0.05 obtained from the t-test; (2) a fold change (FC) ≥ 1.2; (3) a positivity rate ≥ 10% (ccRCC positive reactivity is defined as values greater than the average of the healthy control group plus 2× SD. The positivity rate is calculated as the ratio of ccRCC positive responses to the total number of responses).
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 18 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Carcinoma and Serology, run by First Affiliated Hospital of Fujian Medical University 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 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum autoantibodies (time frame: Prior to any treatment or surgery, 5 mL of venous blood was collected from each individual and allowed to stand at room temperature (RT) for 1 hour to facilitate coagulation.). 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 18 Sep 2025.