Clinical trial · Observational
Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma
Evaluation of Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Osteosarcoma and Ewing sarcoma treatment has not changed in the last 30 years. For other types of cancer the epidemiologic and prognostic correlations between dietary behavior, lifestyle and metabolic alterations (i.e.obesity, insulin-resistance) are well known (breast cancer, prostate cancer, colon cancer). However, no epidemiological or prognostic data are available about the metabolic profile and lifestyle behaviors in patients with osteosarcoma and Ewing'sarcoma and only few preclinical studies are available. An in vitro study showed a higher glucose and glutamine consumption from metastatic osteosarcoma cells compared to primary tumor osteosarcoma cells. The effect of the intestinal microbiota into the metabolism of nutrients, drugs, inflammation, epigenetic and immune response was found not only correlated to gastrointestinal tumors but also to other tumors outside gastrointestinal system as well The aim of this study is to investigate if there are differential dietary habits, metabolome, microbiota or immune profile in patients with bone sarcoma compared to a control population in a 1:2 multicenter study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPIC-COS Food Frequency Questionnaire diet Evaluation | Other | — | UNRESOLVED |
| Metabolome, Microbiota, Lymphocytes subpopulations | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- GROUP 1 - 215 Patients and 430 Control cases (1:2)
- description
- Patients of \>= 12 years old (pediatric and adults) with new diagnosis of osteosarcoma and Ewing sarcoma will be included * Localized and metastatic * Male and female Control cases matched by age, sex and italian geographic area
- interventionNames
- Other: EPIC-COS Food Frequency Questionnaire diet Evaluation
- label
- GROUP 2 - Pilot Phase :55 Patients and 110 Control cases (1:2)
- description
- * Patients of \>= 12 years old (pediatric and adults) with new diagnosis of osteosarcoma and Ewing sarcoma will be included Localized and metastatic Male and female * Control cases matched by age, sex, and geographic area
- interventionNames
- Other: EPIC-COS Food Frequency Questionnaire diet Evaluation
- Other: Metabolome, Microbiota, Lymphocytes subpopulations
Primary outcomes (4)
- measure
- Diet habits in patients versus case controls measured by EPIC COS FFQ
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Osteosarcoma and Ewing sarcoma first diagnosis * No previous chemotherapy treatment * ≥ 12 years old * Able to understand the questionnaire * No malignant tumor diagnosis for the last 5 years * Control case should have a range of +/- 2 years old for patients \>= 21 years old. For patients between 12 and 21 years old the difference should be +/- 1 years. Exclusion Criteria: * Other tumor type * Not able to understand the questionnaire * Patient diagnosed for malignant tumor during the last 5 years
References
Publications (6)
- RESULTFulbright LE, Ellermann M, Arthur JC. The microbiome and the hallmarks of cancer. PLoS Pathog. 2017 Sep 21;13(9):e1006480. doi: 10.1371/journal.ppat.1006480. eCollection 2017 Sep. No abstract available. PMID 28934351
- RESULTGarrett WS. Cancer and the microbiota. Science. 2015 Apr 3;348(6230):80-6. doi: 10.1126/science.aaa4972. PMID 25838377
- RESULTLynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available. PMID 27974040
- RESULTSoldati L, Di Renzo L, Jirillo E, Ascierto PA, Marincola FM, De Lorenzo A. The influence of diet on anti-cancer immune responsiveness. J Transl Med. 2018 Mar 20;16(1):75. doi: 10.1186/s12967-018-1448-0. PMID 29558948
- RESULTFritsche-Guenther R, Gloaguen Y, Kirchner M, Mertins P, Tunn PU, Kirwan JA. Progression-Dependent Altered Metabolism in Osteosarcoma Resulting in Different Nutrient Source Dependencies. Cancers (Basel). 2020 May 27;12(6):1371. doi: 10.3390/cancers12061371. PMID 32471029
- RESULTAlbini A, Briga D, Conti M, Bruno A, Farioli D, Canali S, Sogno I, D'Ambrosio G, Consonni P, Noonan DM. SANIST: a rapid mass spectrometric SACI/ESI data acquisition and elaboration platform for verifying potential candidate biomarkers. Rapid Commun Mass Spectrom. 2015 Oct 15;29(19):1703-10. doi: 10.1002/rcm.7270. PMID 26331920