The Predictive Value of Serum Histone Succinylation in Malignant Solid Tumors

NCT ID: NCT07132606

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-08-01

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

Conditions

Malignant Tumors

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

500 patients with malignant solid tumors

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

No interventions assigned to this group

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yinghua Ji

OTHER

Sponsor Role: lead

Responsible Party

Yinghua Ji

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Wang Fang Doctor, Graduate Student

Role: CONTACT

583573667@qq.com

18337312280

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Chase 016

Identifier Type: OTHER

Identifier Source: secondary_id

CHASE 016

Identifier Type: -

Identifier Source: org_study_id