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

NCT ID: NCT06917560

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Carcinoma Serology Autoantibody

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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first hospital affiliated of Fujian medical university

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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MRCTA,ECFAH OfFMUI2024]697

Identifier Type: -

Identifier Source: org_study_id

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