An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma

NCT05759325 | Not Yet Recruiting

• 1 other identifier: ESCC ctDNA-MRD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous cell carcinoma.

Conditions

Squamous Cell Carcinoma of Esophagus

Keywords

ESCC; ctDNA

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period

  up to 2 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Esophageal squamous cell carcinoma patients who were initially diagnosed as stage II-IVA (TNM V8) and planned to undergo radical surgery

You may qualify if:

• Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;
• ≥18 years;
• Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 \~ 1 points;
• Expected survival time ≥ 6 months;
• Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.

You may not qualify if:

• Patients with other malignant tumors;
• Patient had undergone surgery before admission;
• Pregnant or lactating women;
• Patients with other serious diseases;
• Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;
• Patients with contraindications to radiotherapy and chemotherapy;
• Other researchers think it is not suitable.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood before and after surgery, 2 weeks after the end of adjuvant treatment, follow-up period (every 3 months if there is no postoperative treatment), the progress of the disease, as well as the pathological tissues of the initial diagnosis puncture or surgical resection

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GuangzhouIRD

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 8, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 8, 2023

Record last verified: 2023-02