Investigating dietary habits and metabolic profiles in bone sarcoma patients
Evaluation of Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma
This study is trying to see how the eating habits and body profiles of young people with bone sarcoma, like osteosarcoma and Ewing sarcoma, might be linked to their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 810 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Candiolo, Torino and 6 other locations) |
| Trial ID | NCT04735289 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the dietary habits, metabolome, immune profiles, and microbiota of patients diagnosed with osteosarcoma and Ewing sarcoma. It will include 270 patients aged 12 and older, who will undergo a detailed dietary intake assessment using the EPIC-COS food frequency questionnaire, along with anthropometric measurements. Additionally, a pilot study will analyze metabolomic and microbiota data from a subset of patients and matched controls. Blood samples will be collected for metabolomics and immune profiling, with statistical analyses to identify associations between dietary habits and bone sarcoma risk.
Who should consider this trial
Good fit: Ideal candidates are patients aged 12 and older with a first diagnosis of osteosarcoma or Ewing sarcoma who have not received prior chemotherapy.
Not a fit: Patients with other types of tumors or those who have had a malignant tumor diagnosis in the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how dietary and metabolic factors influence bone sarcoma, potentially leading to improved prevention and treatment strategies.
How similar studies have performed: While there is limited data on dietary and metabolic factors in bone sarcoma, similar studies in other cancer types have shown promising associations, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Candiolo, Torino and 6 other locations
- IRCCS Candiolo Cancer Institute — Candiolo, Torino, Italy (Not_yet_recruiting)
- Rizzoli Orthopedic Institute - Bologna — Bologna, Italy (Recruiting)
- Ospedale pediatrico Meyer - U.O. Pediatric Oncoematology — Firenze, Italy (Not_yet_recruiting)
- IRCCS Istituto Nazionale Tumori - U.O. Pediatric Oncology — Milano, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria Pisana - U.O. Pediatric Oncoematology — Pisa, Italy (Not_yet_recruiting)
- Regina Elena Cancer Center — Roma, Italy (Not_yet_recruiting)
- Ospedale Regina Margherita - U.O. Pediatric Oncoematology — Torino, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Alessandra Longhi, MD — Istituto Ortopedico Rizzoli - Bologna
- Study coordinator: Alessandra Longhi, MD
- Email: alessandra.longhi@ior.it
- Phone: +39 (051) 6366-991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.