Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

NCT06451393 | Recruiting DMC

• 1 other identifier: E2021088
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.

Conditions

Gastric Cancer; Chemotherapy Effect

Keywords

Advanced gastric cancer; Neoadjuvant chemotherapy; Multimodal; Pathological complete response

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response

  Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.

  Assessed within 30 days after radical resection surgery.

Study Arms (1)

Neoadjuvant chemotherapy with radical tumor resection surgery

(i) Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection; (ii) patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling; (iii) patients with insufficient data.

Drug: Neoadjuvant chemotherapy with radical tumor resection surgery

Interventions

Neoadjuvant chemotherapy with radical tumor resection surgery DRUG

All patients were pathologically diagnosed as advanced gastric cancer, all receive neoadjuvant chemotherapy, after the completion of neoadjuvant chemotherapy, all patients receive radical tumor resection surgery (partial gastrectomy or total gastrectomy, as proper).

Neoadjuvant chemotherapy with radical tumor resection surgery

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;

You may qualify if:

• patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
• patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
• Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1

You may not qualify if:

• Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
• patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
• patients with insufficient data.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Junsheng Peng, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghe Chen, MD

CONTACT

+86 135 6038 6150; chenyhe@mail2.sysu.edu.cn

Junsheng Peng, MD

CONTACT

+86 13802963578; pengjsh@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: February 1, 2013
• Primary Completion: September 30, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (1)