P53 Mutation in Esophageal CancerNCT07722819
ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance
An observational study of P53 Mutation in Esophageal Cancer, run by Ling Zhiqiang at 1 site in China.
Trial summary
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- P53 Mutation in Esophageal Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2026to 13 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Adult, Older adult
Study population: This is a single-center, retrospective cohort study. The study population consists of histologically confirmed esophageal squamous cell carcinoma (ESCC) patients who underwent surgical resection at Zhejiang Cancer Hospital between 2015 and 2024. All patients had available p53 molecular data and complete clinical follow-up information.
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma (ESCC); Age ≥ 18 years; Undergone surgical resection; Availability of p53 molecular data and clinical follow-up data.
Who cannot join
- Incomplete medical records or missing key clinicopathological data. Non-squamous histological types.
Trial locations and contacts
1 site in 1 country.
About this study
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc. DNA sequencing was performed on 300 collected esophageal cancer samples, divided into mutant and wild-type types. Perform immunohistochemistry on tissue slices and observe the expression of P53 mutant protein. ELISA was used to study the expression of serum anti-P53 autoantibodies. Process these data and use them to classify subtypes of esophageal cancer. Associate each subtype with clinical information, analyze the characteristics of each subtype, such as the multidimensional features of P53 and treatment correlation analysis, and the correlation between P53 multidimensional features and survival.
Read the detailed description
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis. Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients; Kaplan Meier curve analysis of the relationship between this subtype and patient survival, as well as its expression for cancer risk assessment.
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis.
Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients;
Kaplan Meier curve analysis of the relationship between this subtype and patient survival, as well as its expression for cancer risk assessment.
- Conditions
- P53 Mutation in Esophageal Cancer
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from surgery to death from any cause (for Overall Survival) or to disease recurrence/local-regional failure (for Recurrence-Free Survival).
Measured: Data collected up to December 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start21 Apr 2026
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for P53 Mutation in Esophageal CancerStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ling Zhiqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Zhiqiang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722819
- Sponsor's protocol ID
- IRB-2026-482（IIT）
- Other IDs
- 2021-40
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance
- ClinicalTrials.gov ID
- NCT07722819
- Acronym / sponsor ID
- IRB-2026-482（IIT）
- Conditions
- P53 Mutation in Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ling ZhiqiangUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 23 Jul 2026 (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.
Collect 300 esophageal cancer tissue specimens, including cancer tissue and serum, from a biological sample bank. Collect clinical information on esophageal cancer, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc. DNA sequencing was performed on 300 collected esophageal cancer samples, divided into mutant and wild-type types. Perform immunohistochemistry on tissue slices and observe the expression of P53 mutant protein. ELISA was used to study the expression of serum anti-P53 autoantibodies. Process these data and use them to classify subtypes of esophageal cancer. Associate each subtype with clinical information, analyze the characteristics of each subtype, such as the multidimensional features of P53 and treatment correlation analysis, and the correlation between P53 multidimensional features and survival.
Detailed description
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis. Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients; Kaplan Meier curve analysis of the relationship between this subtype and patient survival, as well as its expression for cancer risk assessment.
Specific research design
- Collect information on all clinical cases of esophageal cancer in the study, including gender, age, time of diagnosis, time of death, treatment information, TNM staging, tumor size, location, etc.
- Perform DNA sequencing on the collected esophageal cancer tissue samples, identify gene mutation sites, and group them according to different types of mutations.
- Perform ELISA on the collected serum of esophageal cancer patients to distinguish between groups with negative and positive autoantibodies.
- Perform immunohistochemistry on tumor tissue slices collected from esophageal cancer patients, observe the expression of mutant P53 protein, and obtain samples with positive immunohistochemistry for P53 protein.
- Based on the presence or absence of P53 mutations, the expression of mutant P53 protein in immunohistochemistry, and the positive or negative autoantibodies in serum, further subtype classification criteria will be developed.
- Associate different subtypes of esophageal cancer with clinical and pathological features, identify their respective characteristics, and provide guidance for clinical diagnosis, treatment, and prognosis.
Univariate and multivariate survival analysis of clinical pathological parameters and the correlation between this subtype and DFS and OS in cancer patients;
Kaplan Meier curve analysis of the relationship between this subtype and patient survival, as well as its expression for cancer risk assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a single-center, retrospective cohort study. The study population consists of histologically confirmed esophageal squamous cell carcinoma (ESCC) patients who underwent surgical resection at Zhejiang Cancer Hospital between 2015 and 2024. All patients had available p53 molecular data and complete clinical follow-up information.
Key inclusion criteria (1 listed)
- Histologically confirmed esophageal squamous cell carcinoma (ESCC); Age ≥ 18 years; Undergone surgical resection; Availability of p53 molecular data and clinical follow-up data.
Key exclusion criteria (1 listed)
- Incomplete medical records or missing key clinicopathological data. Non-squamous histological types.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Retrospective Cohort |
Primary outcome
Time from surgery to death from any cause (for Overall Survival) or to disease recurrence/local-regional failure (for Recurrence-Free Survival).
Time frame: Data collected up to December 31, 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of P53 Mutation in Esophageal Cancer, run by Ling Zhiqiang at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from surgery to death from any cause (for Overall Survival) or to disease recurrence/local-regional failure (for Recurrence-Free Survival). (time frame: Data collected up to December 31, 2024). 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 23 Jul 2026.