NCT06561178Recruiting
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)
Source: ClinicalTrials.gov · Last updated 29 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 12 Aug 2024
- Start date
- 26 Aug 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- NCT number
- NCT06561178
What you commit to
- Study type: Observational
- Planned participants: 50
- From 26 Aug 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other malignant tumors;
Other illness
- Severe and/or poorly controlled medical conditions that, in the investigator's judgment, could affect participation or interfere with study results;
Other
- Lack of a detailed histopathological diagnostic report for determining the nature of the lesion;
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.