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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05759325

Enrollment

100

Registered

2023-03-08

Start date

2023-03-31

Completion date

2026-12-31

Last updated

2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma of Esophagus

Keywords

ESCC, ctDNA

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	up to 2 year	Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period

Outcome results