Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma

NCT04735289 | Unknown

• 1 other identifier: 919/2020/Oss/IOR
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 7

Brief Summary

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

Osteosarcoma; Ewing Sarcoma

Keywords

Metabolome; Microbiota; Bone sarcoma; Immune profile; Dietary habits

Outcome Measures

Primary Outcomes (4)

• Diet habits in patients versus case controls measured by EPIC COS FFQ

  Diet habits from osteosarcoma and Ewing sarcoma patients will be compared with diet habits from a control population. The diet habits data will be evaluated EPIC COS FFQ( European Prospective Investigation Into Cancer and Nutrition Case Only Study Food Frequency Questionnaire) which report: the food consumptions in the last 12 months \- Main food groups (water and other drinks, grain products, fruits and vegetables, legumes, meat and fish products, dairy products, sweets and savory snacks) FFQ-EPIC COS can be accessed on PubMed (PMID: 12484126 and PMID: 12484120).

  At diagnosis, up to 4 years

• Diet Quality Index -

  Diet quality index from osteosarcoma and Ewing sarcoma patients will be compared with diet habits from a control population. Data will be accessed with EPIC COS FFQ( European Prospective Investigation Into Cancer and Nutrition Case Only Study Food Frequency Questionnaire ) \- Diet quality index will be calculated to compare adherence to dietery guidelines and it will be expressed in percentage

  At diagnosis, up to 4 years

• Number of patients overweight and obese measured by Body mass index (BMI compared to controls)

  Body Mass Index (BMI) measure will be achieved in patients and controls by impedance Tanita scale model BC545 based on height (in centimeters) and weight (in Kilograms) expressed in subjects \>18yrs as 1) underweight if \<18.5, 2) normal weight 18.5 to 25,3)overweight 25-30 and 4) obese \>30. BMI measure will be achieved by impedance Tanita scale model BC545 in study patients at diagnosis and compared with a control subjects.

  At diagnosis, up to 4 years

• Body composition

  Lean mass and fat mass will be calculated via impedance Tanita scale model BC545 as a percentage of total weight .Lean body mass is the difference between total body weight and body fat weight, expressed as percentage (%)

  At diagnosis, up to 4 years

Secondary Outcomes (4)

• Concentration of blood metabolites - Metabolome

  At diagnosis, up to 4 years

• Microbiota

  At diagnosis, up to 4 years

• Concentrations of lymphocytes subpopulation

  At diagnosis, up to 4 years

• Lipid profile and Glucidic profile

  At diagnosis, up to 4 years

Study Arms (2)

GROUP 1 - 215 Patients and 430 Control cases (1:2)

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

Other: EPIC-COS Food Frequency Questionnaire diet Evaluation

GROUP 2 - Pilot Phase :55 Patients and 110 Control cases (1:2)

* 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

Other: EPIC-COS Food Frequency Questionnaire diet Evaluation; Other: Metabolome, Microbiota, Lymphocytes subpopulations

Interventions

EPIC-COS Food Frequency Questionnaire diet Evaluation OTHER

Anthropometric measurements (Body mass Index, Lean and fat body composition evaluation) and diet habits evaluation with EPIC-COS-FFQ

Also known as: EPIC-FFQ diet Evaluation

GROUP 1 - 215 Patients and 430 Control cases (1:2); GROUP 2 - Pilot Phase :55 Patients and 110 Control cases (1:2)

Metabolome, Microbiota, Lymphocytes subpopulations OTHER

At diagnosis before any treatment for bone sarcoma will be obtained : 1. a blood sample for metabolomics analyses 2. a stool sample for microbiota analysis 3. Lymphocyte subpopulations (CD3, CD4, CD8, NK) will be analyzed in blood samples

GROUP 2 - Pilot Phase :55 Patients and 110 Control cases (1:2)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients will be selected from the central and satellite centers * Control group will be selected from the same age, sex, geographic area of the recruited patients

You may qualify if:

• 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.

You may not qualify if:

• Other tumor type
• Not able to understand the questionnaire
• Patient diagnosed for malignant tumor during the last 5 years

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• International Agency for Research on Cancer: collaborator

Study Sites (7)

IRCCS Candiolo Cancer Institute

Candiolo, Torino, 10060, Italy

NOT YET RECRUITING

Rizzoli Orthopedic Institute - Bologna

Bologna, 40136, Italy

RECRUITING

Ospedale pediatrico Meyer - U.O. Pediatric Oncoematology

Florence, 50139, Italy

NOT YET RECRUITING

IRCCS Istituto Nazionale Tumori - U.O. Pediatric Oncology

Milan, 20133, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Pisana - U.O. Pediatric Oncoematology

Pisa, 56126, Italy

NOT YET RECRUITING

Regina Elena Cancer Center

Roma, 00144, Italy

NOT YET RECRUITING

Ospedale Regina Margherita - U.O. Pediatric Oncoematology

Torino, 10126, Italy

NOT YET RECRUITING

Related Publications (6)

• Fulbright 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 RESULT

• Garrett WS. Cancer and the microbiota. Science. 2015 Apr 3;348(6230):80-6. doi: 10.1126/science.aaa4972.

  PMID: 25838377 RESULT

• Lynch 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 RESULT

• Soldati 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 RESULT

• Fritsche-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 RESULT

• Albini 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Inside this main study (270:540) a pilot study of 55 patients and 110 controls of same age, sex, geographic area (1:2) will be performed for analysis of metabolome, microbiota, and immune profile. At diagnosis before any treatment a blood sample will be obtained for metabolomics analyses (untargeted approach with over 100.000 of metabolites, (Mass Spectrometry method) and to evaluate lymphocyte subpopulations (CD3, CD4, CD8, NK) in blood. Microbiota will be analyzed in donated stool samples using the S16 method. All data will be analyzed for inter-correlations among the different parameters and to investigate putative associations with Food Frequency questionnaires and anthropometric data.

MeSH Terms

Conditions

Osteosarcoma; Sarcoma, Ewing; Bone Neoplasms; Feeding Behavior

Interventions

Metabolome; Microbiota

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Metabolism; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Alessandra Longhi, MD

  Istituto Ortopedico Rizzoli - Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Longhi, MD

CONTACT

+39 (051) 6366-991; alessandra.longhi@ior.it

Inge Huybrechts, PhD

CONTACT

huybrechtsl@iarc.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: February 3, 2021
• Study Start: March 10, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

IT (7)