Serological Autoantibodies in Early Kidney Cancer Diagnosis and Prognosis: A Multicenter Study

NCT06917560 | Active Not Recruiting

• 1 other identifier: MRCTA,ECFAH OfFMUI2024]697
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed renal cell carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator

Study Sites (1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)