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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Renal Carcinoma Adenocarcinoma Autoantibody Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Serology Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, 350005, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Collaborators

China-Japan Friendship Hospital
The First Affiliated Hospital of Xiamen University

Registry information

Official study title

The Role of Serological Autoantibody Profiles in the Early Diagnosis and Prognosis of Renal Carcinoma: A Multicenter, Retrospective Clinical Study

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Apr 8, 2025
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting