Skip to main content
OpenTrials
Completed

NCT Number: NCT07722819

ESCC Molecular Subtypes Based on Multidimensional Features of p53 and Their Clinical Significance

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed esophageal squamous cell carcinoma (ESCC); Age ≥ 18 years; Undergone surgical resection; Availability of p53 molecular data and clinical follow-up data.

Exclusion criteria

  • Incomplete medical records or missing key clinicopathological data. Non-squamous histological types.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ling Zhiqiang

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.