The Predictive Value of Serum Histone Succinylation in Malignant Solid Tumors

NCT07132606 | Not Yet Recruiting DMC

• 2 other identifiers: CHASE 016Chase 016
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• Evaluate the positive rate of serum histone succinylation in patients with malignant solid tumors

  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

  2025.08.01-2026.12.31

Secondary Outcomes (1)

• Define the relationship between histone succinylation modifications in serum and different tumor types as well as tumor staging

  2025.08.01-2026.12.31

Study Arms (1)

500 patients with malignant solid tumors

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

Eligibility Criteria

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

Study Population

Patients with malignant tumors and healthy individuals

You may qualify if:

• 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；

You may not qualify if:

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

Sponsors & Collaborators

• Yinghua Ji: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Wang Fang Doctor, Graduate Student

CONTACT

18337312280; 583573667@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 20, 2025
• Study Start: August 20, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 2025.08.01-2026.12.31