MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
MOONRISE
1 other identifier
observational
125
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2022
CompletedFirst Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 13, 2023
February 1, 2023
6 years
January 24, 2023
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Neoadjuvant Chemotherapy Toxicity
From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
Postoperative Complications
From date of surgery, assessed up to 90 days
Overall Survival
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
From date of inclusion through study completion - an average of 3 years
Interventions
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.
Eligibility Criteria
This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.
You may qualify if:
- Age ≥ 18 years
- Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
- Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM classification
- Qualification for multimodal treatment by the decision of the multidisciplinary tumor board
You may not qualify if:
- Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team
- Gastric stump carcinoma
- Distant metastasis
- Upfront surgery
- Other malignancies
- Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Lublinlead
- Erasmus Medical Centercollaborator
- Ohio State Universitycollaborator
- Poznan University of Medical Sciencescollaborator
- Jagiellonian Universitycollaborator
Study Sites (1)
Medical University of Lublin
Lublin, 20-080, Poland
Related Publications (1)
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.
PMID: 38319910DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zuzanna Pelc, PhD
Medical University of Lublin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2023
First Posted
February 13, 2023
Study Start
December 20, 2022
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 13, 2023
Record last verified: 2023-02