Gastric CancerMOONRISENCT05723718
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Medical University of Lublin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Cancer, Gastric Adenocarcinoma, Malnutrition
- What is being tested?
- Observational Survey
- How many people
- 125 participants
- Where
- 1 sitePoland
- Study dates
- 20 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lublin
Lublin, 20-080
Karol RawiczPruszyński, Professor, 81 531 81 26, karol.rawicz-pruszynski@umlub.pl
About this study
Official title: MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma, Malnutrition, Cachexia
- Being tested
- Observational Survey
- Keywords
- gastric cancer, bioelectrical impedance analysis, body composition, nutritional status, malnutrition, cachexia, multimodal treatment, tumor regression grade
- Medical subject headings
- Stomach Neoplasms, Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational SurveyOther
Also called Nutritional Status and Body Composition Assessment
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Regression Grade
determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)
Measured: Up to 2-4 weeks after the surgery
Secondary outcomes (4)
Neoadjuvant Chemotherapy Toxicity
evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0)
Measured: From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
Postoperative Complications
Assessed by the Comprehensive Complication Index (CCI). Min-Max values (0-100), higher scores mean a worse outcome
Measured: 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
Measured: 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
Measured: From date of inclusion through study completion - an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Dec 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, Ohio State University, Poznan University of Medical Sciences, Jagiellonian University
- Responsible party
- Sponsor
- Investigators
- Zuzanna Pelc, PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723718
- Sponsor's protocol ID
- MOONRISE_2023
- Acronym
- MOONRISE
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38319910
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment - MOONRISE Study
- ClinicalTrials.gov ID
- NCT05723718
- Acronym / sponsor ID
- MOONRISE / MOONRISE_2023
- Conditions
- Gastric Cancer, Gastric Adenocarcinoma, Malnutrition, Cachexia
- Keywords
- gastric cancer, bioelectrical impedance analysis, body composition, nutritional status, malnutrition, cachexia, multimodal treatment, tumor regression grade
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, Ohio State University, Poznan University of Medical Sciences, Jagiellonian University
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include a western population of patients with histologically confirmed, potentially curative esophageal gastro junction and gastric adenocarcinoma scheduled for multimodal treatment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team
- Gastric stump carcinoma
- Distant metastasis
- Upfront surgery
- Other malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational SurveyAlso: Nutritional Status and Body Composition AssessmentEvaluation 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. | Other | – |
Primary outcome
Tumor Regression Grade
Time frame: Up to 2-4 weeks after the surgery
determined using the Becker criteria (1- complete response, 2 - good response, 3 - partial response, 4 - no response)
4 secondary outcomes
Neoadjuvant Chemotherapy Toxicity
Time frame: From date of inclusion up to 1-3 months after the date of the first neoadjuvant chemotherapy cycle
Postoperative Complications
Time frame: From date of surgery, assessed up to 90 days
Overall Survival
Time frame: 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
Time frame: From date of inclusion through study completion - an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Derived from this study: PubMed 38319910Pelc 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuzanna Pelc, PhD principal investigator
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zuzanna Pelc, PhD (+48 81 531 81 26, zuzannapelc@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Regression Grade (time frame: Up to 2-4 weeks after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.