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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-26

Study Completion Date

2028-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05759325

Squamous Cell Carcinoma of Esophagus

NOT_YET_RECRUITING

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

NCT03172156

Non-small Cell Lung Cancer Stage I

COMPLETED

ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS

NCT03465241

NSCLC

COMPLETED

Explore Intra-tumor Heterogeneity and Prognostic Value of Postoperative Blood ctDNA of ⅡA - ⅢA Stage Non-squamous NSCLC Based on the Capture-based Sequencing and UMI Technology of Burning Rock

NCT03337711

Non-small Cell Lung Cancer

UNKNOWN

Identification of Breath Biomarkers in Esophageal Cancer

NCT05557955

Esophageal Squamous Cell Carcinoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

molecular residual disease detection

ctDNA detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No