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NCT Number: NCT05759325

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: up to 2 year

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

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Mar 8, 2023

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.

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