The Predictive Value of Serum Histone Succinylation in Malignant Solid Tumors

Not yet recruiting

• Conditions: Malignant Tumors

• Registration Number: NCT07132606
• Lead Sponsor: Yinghua Ji

Brief Summary

In recent years, advances in protein post-translational modification (PTM) research have revealed histone succinylation as a novel epigenetic modification mechanism critically involved in tumor initiation, progression, and prognosis. Succinylation alters protein physicochemical properties and functions, thereby modulating cellular metabolism, proliferation, and apoptosis. Aberrant histone succinylation in tumor cells demonstrates significant correlations with tumor type, staging, and clinical outcomes, offering new avenues for early cancer diagnosis.

This project utilizes blood serum samples to quantify histone succinylation levels through modification-specific antibody-based detection. Integrated with clinical data, this approach enables early, rapid, and accurate pan-cancer diagnosis, achieving tumor screening via a single-tube blood test. It represents a paradigm shift in precision oncology from "gene-driven" to "epigenetic-metabolic-driven" early detection.

Detailed Description

Primary Objective To evaluate differential expression of serum histone succinylation between malignant solid tumor patients and healthy controls, thereby validating its early detection value.

Secondary Objectives

To determine correlations between serum histone succinylation levels and:

Tumor types Tumor stages

To statistically analyze associations of serum histone succinylation with:

Therapeutic efficacy (surgical intervention, radiotherapy, systemic therapy) Clinicopathological variables

Study Timeline

• Study First Submitted: 2025-07-15
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study Start: 2025-08-20
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Case Group:

• Aged ≥18 years, regardless of sex；
• Histologically or cytologically confirmed malignant solid tumors requiring subsequent anticancer therapy；

Control Group:

• Aged ≥18 years, regardless of sex；
• Non-cancer participants enrolled through health screenings；

Exclusion Criteria

• Pregnant individuals；
• Individuals with serious mental disorders or communication barriers；
• Other conditions deemed by investigators to contraindicate study participation；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the positive rate of serum histone succinylation in patients with malignant solid tumors	2025.08.01-2026.12.31	Evaluate the positive rate of serum histone succinylation in malignant solid tumor patients versus healthy individuals through Western blot analysis, quantify the percentage difference between the two groups, and thereby validate its potential for early cancer screening

Secondary Outcome Measures

Name	Time	Method
Define the relationship between histone succinylation modifications in serum and different tumor types as well as tumor staging	2025.08.01-2026.12.31	Analyze the relationship between histone succinylation modifications in serum and therapeutic efficacy (specifically surgery, radiotherapy, and systemic therapy)。