Neoplasms

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Digestive System Diseases

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Malnutrition

Wasting Syndrome

Cachexia

Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Nutrition Disorders

Body Weight

Weight Loss

Body Weight Changes

Thinness

Metabolic Diseases

Stomach Cancer

Evaluation of the nutritional status and body composition on tumor regression grade in gastric cancer patients scheduled for multimodal treatment. Nutritional status assessment will include: selected clinical variables evaluation (weight, BMI, nutritional status scales), bioelectrical impedance analysis and selected laboratory parameter assessment. After inclusion in the study, each patient will have four consecutive nutritional status assessments: (1) one day prior staging laparoscopy or during qualification to neoadjuvant chemotherapy, (2) one day before the gastrectomy, (3) one month after the gastrectomy, (4) after the last cycle of adjuvant chemotherapy.

Observational Survey

Zuzanna Pelc, PhD

Karol Rawicz-Pruszyński, Professor

Karol RawiczPruszyński, Professor

The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.

Up to 20% of gastric cancer patients experience unintentional loss of their pretreatment body weight. Malnutrition contributes to increased morbidity, higher risk of perioperative complications and systemic toxicity. A standardized approach to evaluate the nutritional status of gastric cancer patients is yet to be established. Bioelectrical impedance analysis is a non-invasive technique estimating changes in body composition over time.

125 patients with locally advanced gastric adenocarcinoma scheduled for multimodal treatment will be included in the study. Four consecutive nutritional status assessments will be performed throughout the treatment.

MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment

MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study

determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)

evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)

Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome

Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients

Assessment based on The European Organization for Research and Treatment of Cancer quality of life, gastric-cancer specific questionnaire(EORTC QLQ - STO22). Min-Max value (1-7); higher scores mean a better outcome

Erasmus Medical Center

Ohio State University

Poznan University of Medical Sciences

Jagiellonian University

Medical University of Lublin

develop and visualized a radio-clinical signatures from pretreatment oversampled CT images to predict the neoadjuvant chemotherapy response and prognosis

develop and visualized a radio-clinical signatures from pretreatment oversampled CT images

Xiangdong Cheng, MD

The early noninvasive screening of patients suitable for neoadjuvant chemotherapy (NCT) is essential for personalized treatment in locally advanced gastric cancer (LAGC). The aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled CT images to predict the response and prognosis to NCT in LAGC patients.

DLCS for Predicting Neoadjuvant Chemotherapy Response

Deep Learning Radio-clinical Signatures for Predicting Neoadjuvant Chemotherapy Response and Prognosis From Pretreatment CT Images of LAGC Patients

Due to the privacy of patients, the data related to patients cannot be available for public access but can be obtained from the corresponding author on reasonable request approved by the institutional review board of all enrolled centers.

Zhejiang Cancer Hospital

Professor

Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC)

TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).

Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC).

response to neoadjuvant chemotherapy

Hualong Zheng

Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking. Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit.

Background: Neoadjuvant chemotherapy (NC) is an important treatment for advanced gastric cancer (AGC). However, tools that effectively predict the efficacy of NC before treatment are lacking.

Methods: Computed tomography images before and after NC were used to construct a deep learning-based radiomics signature to predict the efficacy of NC, prognoses and postoperative adjuvant chemotherapy benefit. Tumor regression grade (TRG) =0 or 1 was defined as a good response to neoadjuvant chemotherapy (GRNC), and TRG=2 or 3 was defined as a poor response to neoadjuvant chemotherapy (PRNC). 193 patients with AGC from January 2010 to December 2018 in two different China university hospitals were included in this study. The before neoadjuvant chemotherapy imaging scoring system (BNCISS), imaging change scoring system before and after neoadjuvant chemotherapy (ICSS), which were constructed based on computed tomography images before after treatment.

Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy

Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy and Postoperative Adjuvant Chemotherapy Benefit in Advanced Gastric Cancer: a Two-center Study

The predictive performance of imaging change scoring system before and after neoadjuvant chemotherapy (ICSS)

The predictive performance of before neoadjuvant chemotherapy imaging scoring system (BNCISS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment	NCT05723718	Gastric Cancer Gastric Adenoca... Malnutrition Cachexia	Observational S...	18 Years - 100 Years	Medical University of Lublin
DLCS for Predicting Neoadjuvant Chemotherapy Response	NCT05617469	Gastric Cancer CT Images Deep Learning Neoadjuvant Che... Tumor Regressio...	develop and vis...	18 Years - 80 Years	Zhejiang Cancer Hospital
Using Radiomics to Predict Neoadjuvant Chemotherapy Efficacy	NCT05465512	Gastric Cancer	response to neo...	18 Years - 85 Years	Fujian Medical University

Spots Global Cancer Trial Database for tumor regression grade