Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05723718
Status:
RECRUITING
Last Update Posted:
2023-02-13
First Post:
2023-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Regression Grade', 'timeFrame': 'Up to 2-4 weeks after the surgery', 'description': 'determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)'}], 'secondaryOutcomes': [{'measure': 'Neoadjuvant Chemotherapy Toxicity', 'timeFrame': 'From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle', 'description': 'evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)'}, {'measure': 'Postoperative Complications', 'timeFrame': 'From date of surgery, assessed up to 90 days', 'description': 'Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome'}, {'measure': 'Overall Survival', 'timeFrame': 'From from the date of surgery to the date of patient death or the date of the last follow-up - up to 10 years', 'description': 'Overall survival analysis will determine whether bioelectrical impedance analysis is a prognostic factor in advanced gastric cancer patients'}, {'measure': 'Quality of Life score', 'timeFrame': 'From date of inclusion through study completion - an average of 3 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'bioelectrical impedance analysis', 'body composition', 'nutritional status', 'malnutrition', 'cachexia', 'multimodal treatment', 'tumor regression grade'], 'conditions': ['Gastric Cancer', 'Gastric Adenocarcinoma', 'Malnutrition', 'Cachexia']}, 'referencesModule': {'references': [{'pmid': '38319910', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n125 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)\n3. Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM classification\n4. Qualification for multimodal treatment by the decision of the multidisciplinary tumor board\n\nExclusion Criteria:\n\n1. Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team\n2. Gastric stump carcinoma\n3. Distant metastasis\n4. Upfront surgery\n5. Other malignancies\n6. Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)'}, 'identificationModule': {'nctId': 'NCT05723718', 'acronym': 'MOONRISE', 'briefTitle': 'MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study', 'orgStudyIdInfo': {'id': 'MOONRISE_2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational Survey', 'type': 'OTHER', 'otherNames': ['Nutritional Status and Body Composition Assessment'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-080', 'city': 'Lublin', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Karol RawiczPruszyński, Professor', 'role': 'CONTACT', 'email': 'karol.rawicz-pruszynski@umlub.pl', 'phone': '81 531 81 26'}], 'facility': 'Medical University of Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}], 'centralContacts': [{'name': 'Zuzanna Pelc, PhD', 'role': 'CONTACT', 'email': 'zuzannapelc@umlub.pl', 'phone': '+48 81 531 81 26'}, {'name': 'Karol Rawicz-Pruszyński, Professor', 'role': 'CONTACT', 'email': 'karol.rawicz-pruszynski@umlub.pl', 'phone': '+48 81 531 81 26'}], 'overallOfficials': [{'name': 'Zuzanna Pelc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Lublin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, {'name': 'Jagiellonian University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}