- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07629921
Multimodal Al for Precision Diagnosis of Esophageal Cancer
2026년 8월 14일 업데이트: Quan-Lin Li, Shanghai Zhongshan Hospital
This study intends to construct two multimodal deep learning models: one for the diagnosis of esophageal cancer and the prediction of invasive depth to assess suitability for endoscopic resection; the other model, based on this, classifies endoscopic non-resectable patients into different degrees of invasion to further explore the differences in the sensitivity and survival of AI-predicted benign and malignant tumors in patients' responses to NAT, thereby providing reliable decision support for precise individualized treatment.
This aspect has rarely been addressed in previous studies.
연구 개요
연구 유형
관찰
등록 (실제)
264
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Shanghai, 중국
- Zhongshan hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
The study population will consist of adult patients (≥18 years) with pathologically confirmed esophageal squamous cell carcinoma (ESCC) who underwent diagnostic endoscopy and contrast-enhanced CT examination at participating centers.
Patients with early-stage disease who received endoscopic resection or esophagectomy and had pathological assessment of tumor invasion depth will be included for development and validation of a multimodal deep learning model for diagnosis and prediction of invasion depth.
Patients with locally advanced disease who received neoadjuvant therapy followed by surgical resection, with available pathological response and follow-up data, will be included for development and validation of a multimodal model for predicting treatment response and prognosis.
Clinical information, CT images, endoscopic images, pathological findings, and survival outcomes will be collected for analysis.
설명
Inclusion Criteria:
- Age ≥18 years.
- Histologically confirmed or clinically suspected esophageal squamous cell carcinoma (ESCC).
- Availability of pre-treatment endoscopic images and contrast-enhanced chest/upper abdominal CT scans.
- Availability of complete clinical and pathological data.
- Patients who underwent endoscopic resection (ESD/EMR) or esophagectomy with pathological assessment of tumor invasion depth.
- Adequate image quality for analysis.
- Written informed consent (for prospective cohorts, if applicable).
Exclusion Criteria:
- Histology other than squamous cell carcinoma.
- Prior treatment for esophageal cancer before baseline imaging, including chemotherapy, radiotherapy, immunotherapy, or endoscopic resection.
- Distant metastatic disease at diagnosis.
- Incomplete clinical, imaging, or pathological data.
- Poor-quality CT or endoscopic images unsuitable for analysis.
- History of another active malignancy within the past 5 years.
- Recurrent esophageal cancer.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
ESD
|
Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms.
The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope.
After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria.
A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer.
Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed.
The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation.
Post-resection inspection of the artificial ulcer is performed to assess for bleeding
|
|
ESD+surgery
|
Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection.
The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria.
Surgical treatment is performed according to institutional standards and current clinical guidelines.
Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms.
The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope.
After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria.
A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer.
Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed.
The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation.
Post-resection inspection of the artificial ulcer is performed to assess for bleeding
|
|
NAT +surgery
|
Neoadjuvant therapy has become a standard treatment strategy for patients with locally advanced esophageal squamous cell carcinoma (ESCC).
Administered before surgical resection, neoadjuvant treatment aims to reduce tumor burden, downstage disease, increase the likelihood of complete (R0) resection, and improve long-term survival outcomes.
Current neoadjuvant approaches include chemotherapy, chemoradiotherapy, and more recently, immune checkpoint inhibitor-based combination therapies.
Among these, neoadjuvant immunochemotherapy has demonstrated promising pathological response rates and survival benefits, emerging as an important treatment option for ESCC.
However, treatment response varies considerably among patients, highlighting the need for reliable predictive models to guide individualized therapeutic decision-making.
Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection.
The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria.
Surgical treatment is performed according to institutional standards and current clinical guidelines.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Actual receipt of additional surgery
기간: 1 week
|
Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.
|
1 week
|
|
Presence of pathological indications for additional surgery
기간: 1 week
|
According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).
|
1 week
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 3월 1일
기본 완료 (실제)
2026년 1월 1일
연구 완료 (실제)
2026년 6월 7일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 14일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .