Malignant TumorsNCT07132606
The Predictive Value of Serum Histone Succinylation in Malignant Solid Tumors
An observational study of Malignant Tumors, run by Yinghua Ji.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumors
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 1 Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with malignant tumors and healthy individuals
Who may be able to join
- 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；
Who cannot join
- Pregnant individuals；
- Individuals with serious mental disorders or communication barriers；
- Other conditions deemed by investigators to contraindicate study participation；
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serum Histone Succinylation: A Predictive Biomarker for Malignant Solid Tumors
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.
Read the 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 500 patients with malignant solid tumors | Aged ≥18 years, regardless of sex； Histologically or cytologically confirmed malignant solid tumors requiring subsequent anticancer therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Analyze the relationship between histone succinylation modifications in serum and therapeutic efficacy (specifically surgery, radiotherapy, and systemic therapy)。
Measured: 2025.08.01-2026.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yinghua Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yinghua Ji, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132606
- Sponsor's protocol ID
- CHASE 016
- Other IDs
- Chase 016
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Histone Succinylation: A Predictive Biomarker for Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07132606
- Acronym / sponsor ID
- CHASE 016
- Conditions
- Malignant Tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yinghua JiUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 500 patients with malignant solid tumors | – | –Aged ≥18 years, regardless of sex； Histologically or cytologically confirmed malignant solid tumors requiring subsequent anticancer therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant tumors and healthy individuals
Key inclusion criteria (6 listed)
- Aged ≥18 years, regardless of sex；
- Histologically or cytologically confirmed malignant solid tumors requiring subsequent anticancer therapy；
- Aged ≥18 years, regardless of sex；
- Non-cancer participants enrolled through health screenings；
Key exclusion criteria (3 listed)
- Pregnant individuals；
- Individuals with serious mental disorders or communication barriers；
- Other conditions deemed by investigators to contraindicate study participation；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the positive rate of serum histone succinylation in patients with malignant solid tumors
Time frame: 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
1 secondary outcome
Define the relationship between histone succinylation modifications in serum and different tumor types as well as tumor staging
Time frame: 2025.08.01-2026.12.31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumors, run by Yinghua Ji.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Fang Doctor, Graduate Student (18337312280, 583573667@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the positive rate of serum histone succinylation in patients with malignant solid tumors (time frame: 2025.08.01-2026.12.31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.