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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Ohio State University | OTHER |
| Poznan University of Medical Sciences | OTHER |
| Jagiellonian University |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Survey | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Regression Grade | determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response) | Up to 2-4 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Neoadjuvant Chemotherapy Toxicity | evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) | From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle |
| Postoperative Complications |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuzanna Pelc, PhD | Contact | +48 81 531 81 26 | zuzannapelc@umlub.pl | |
| Karol Rawicz-PruszyĆski, Professor | Contact | +48 81 531 81 26 | karol.rawicz-pruszynski@umlub.pl |
| Name | Affiliation | Role |
|---|---|---|
| Zuzanna Pelc, PhD | Medical University of Lublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Lublin | Recruiting | Lublin | 20-080 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38319910 | Derived | Pelc Z, Sedlak K, Mlak R, Chawrylak K, Mielniczek K, Lesniewska M, Skorzewska M, Kwietniewska M, Pasnik I, Geca K, van der Sluis P, Banasiewicz T, Pedziwiatr M, Polkowski WP, Pawlik TM, Malecka-Massalska T, Rawicz-Pruszynski K. MalnutritiOn assessment with biOelectrical impedaNce analysis in gastRic cancer patIentS undergoing multimodaltrEatment (MOONRISE)-Study protocol for a single-arm multicenter cross-sectional longitudinal study. PLoS One. 2024 Feb 6;19(2):e0297583. doi: 10.1371/journal.pone.0297583. eCollection 2024. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D044342 | Malnutrition |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| OTHER |
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Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome |
| From date of surgery, assessed up to 90 days |
| Overall Survival | Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients | From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years |
| Quality of Life score | 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 | From date of inclusion through study completion - an average of 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D003710 | Demography |
| D011154 | Population Characteristics |