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

NCT06561178 | Recruiting DMC

• 1 other identifier: B2024-302-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

ctDNA; recurrence detection; esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Postoperative molecular residual disease (MRD) positive rate

  3 years

• Correlation between ctDNA detection and postoperative adjuvant therapy.

  3 years

• correlation between patients' prognosis and landmark MRD status

  3 years

• 2-year disease-free survival

  2 years

• 3-year disease-free survival

  3 years

Interventions

molecular residual disease detection DIAGNOSTIC_TEST

ctDNA detection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

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 Officials

• Hong Yang, M.D.;Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Yang, MD

CONTACT

86-020-87343932; yanghong@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 19, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)