Individualized Tumor-Informed CtDNA Analysis for Monitoring Postoperative Recurrence in ESCC (NEOCRTEC2401)

Individualized Tumor-Informed Circulating Tumor DNA (ctDNA) Analysis for Monitoring Postoperative Recurrence Following Neoadjuvant Therapy in Esophageal Squamous Cell Carcinoma (NEOCRTEC2401)

The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:

Is there a correlation between postoperative ctDNA changes and tumor recurrence?

Participants will be asked to undergo postoperative ctDNA detection.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Hong Yang, MD; Phone Number: 020-87343932 86-020-87343932; Email: yanghong@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with esophageal squamous cell carcinoma who have not achieved pCR following neoadjuvant chemoradiotherapy and surgery.

Description

Inclusion Criteria:

1. Operable locally advanced esophageal squamous cell carcinoma;
2. Have received neoadjuvant chemoradiotherapy ± immunotherapy and have not achieved pCR after R0 resection;
3. Can tolerate postoperative adjuvant immunotherapy;
4. Sufficient baseline tumor tissue and blood samples available for NGS testing;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
6. Consents to and is capable of complying with the scheduled study visits, treatment plans, laboratory tests, and other study procedures
7. Expected postoperative survival time of ≥ 6 months.

Exclusion Criteria:

1. Concurrent other malignant tumors;
2. Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
3. Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
4. Any social/psychological issues that, in the investigator's judgment, make the patient unsuitable for participation;
5. Unable to undergo long-term, regular postoperative follow-up at the current medical institution;
6. Unwilling or unable to comply with the study protocol.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.	Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year overall survival		2 years
3-year overall survival		3 years
3-year disease-free survival		3 years
2-year disease-free survival		2 years
5-year overall survival		5 years
Correlation between ctDNA detection and postoperative adjuvant therapy.	The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis.	3 years
correlation between patients' prognosis and landmark MRD status	The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis.	3 years
5-year disease-free survival		5 years
Postoperative molecular residual disease (MRD) positive rate		3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ctDNA; esophageal squamous cell carcinoma; recurrence detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Recurrence; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: B2024-302-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No