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

Squamous Cell Carcinoma of Esophagus Clinical Trial

Official title:

Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05759325
• Other study ID #: ESCC ctDNA-MRD
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

ESCC patients with II-IVA resection will undergo MRD examination at the following time: the first examination is before the operation, the second examination is 7-10 days after the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant treatment (if available), the follow-up period (every 3 months if there is no postoperative treatment) and the progress (the progress of the disease confirmed by the researcher), the patients will receive close MRD monitoring to evaluate the correlation between ctDNA-MRD and therapeutic efficacy and prognosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;

2. =18 years;

3. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;

4. Expected survival time = 6 months;

5. Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.

Exclusion Criteria:

1. Patients with other malignant tumors;

2. Patient had undergone surgery before admission;

3. Pregnant or lactating women;

4. Patients with other serious diseases;

5. Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;

6. Patients with contraindications to radiotherapy and chemotherapy;

7. Other researchers think it is not suitable.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Esophagus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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