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NCT Number: NCT06561178

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

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Hong Yang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

molecular residual disease detection

Diagnostic Test

ctDNA detection

Primary outcomes

  1. Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration.

    Time frame: 3 years

    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.

Secondary outcomes

  1. Postoperative molecular residual disease (MRD) positive rate

    Time frame: 3 years

  2. Correlation between ctDNA detection and postoperative adjuvant therapy.

    Time frame: 3 years

    The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis.

  3. correlation between patients' prognosis and landmark MRD status

    Time frame: 3 years

    The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis.

  4. 2-year disease-free survival

    Time frame: 2 years

  5. 3-year disease-free survival

    Time frame: 3 years

  6. 5-year disease-free survival

    Time frame: 5 years

  7. 2-year overall survival

    Time frame: 2 years

  8. 3-year overall survival

    Time frame: 3 years

  9. 5-year overall survival

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Yang, MD

CONTACT

[email protected]

86-020-87343932 ext. 020-87343932

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen University Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2024
Registry last updated
Aug 29, 2024

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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