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OsteosarcomaMetabol-SarcNCT04735289

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

An observational study of Osteosarcoma and Ewing Sarcoma, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Osteosarcoma, Ewing Sarcoma
What is being tested?
EPIC-COS Food Frequency Questionnaire diet Evaluation and Metabolome, Microbiota, Lymphocytes subpopulations
How many people
810 participants
Where
7 sitesItaly
Study dates
10 Mar 2021to 31 Dec 2024
How long will I take part?
4 Years
Phase
Observational
Are there results?
None posted in the registry

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 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

Alessandra Longhi, MD contact

+39 (051) 6366-991

alessandra.longhi@ior.it

Inge Huybrechts, PhD contact

huybrechtsl@iarc.fr

7 sites in 1 country

Italy7 sites, 7 recruiting

  • Rizzoli Orthopedic Institute - Bologna

    Bologna, 40136

    Alessandra Longhi, MD, +39 (051) 6366.991, alessandra.longhi@ior.it

    Recruiting

  • IRCCS Candiolo Cancer Institute

    Candiolo, Torino, 10060

    Giovanni Grignani, MD

    Not yet recruiting

  • Ospedale pediatrico Meyer - U.O. Pediatric Oncoematology

    Florence, 50139

    Angela Tamburini, MD

    Not yet recruiting

  • IRCCS Istituto Nazionale Tumori - U.O. Pediatric Oncology

    Milan, 20133

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Pisana - U.O. Pediatric Oncoematology

    Pisa, 56126

    Luca Coccoli, MD

    Not yet recruiting

  • Regina Elena Cancer Center

    Roma, 00144

    Virginia Ferraresi, MD

    Not yet recruiting

  • Ospedale Regina Margherita - U.O. Pediatric Oncoematology

    Torino, 10126

    Franca Fagioli, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: Evaluation of Dietary Habits, Metabolome, Immune Profile and Microbiota in Patients With Bone Sarcoma

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.

Read the detailed description

MATERIALS \& METHODS A population of 270 patients of >12 yrs old (pediatric and adults) with new diagnosis of osteosarcoma and Ewing sarcoma will be included. A detailed dietary intake assessment will be done with EPIC-COS food frequency questionnaire (FFQ) and anthropometric measures (Weight, Height, body fat/lean mass composition) will be taken at diagnosis before treatment and compared to 540 controls matched by age, sex, and italian geographic area.

In addition, inside this main study a pilot study of 55 patients and 110 controls of same age, sex, geographic area 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 EPIC-COS Food Frequency questionnaires and anthropometric data .

STATISTICAL ANALYSIS Conditional logistic regression analyses will be used to calculate odds ratio (OR) and 95% confidence interval (CI) to investigate associations between dietary habits and bone sarcoma risk in the case control study. An odds ratio of 1.6 with a potency of 85% was considered in the sample size calculations, leading to a target sample size of 270 cases with 540 matched healthy controls.

For the pilot cohort samples of 55 cases and 110 controls will be analyzed for metabolome, microbiota and immune profile. According to the results of this pilot study further cases among the population of FFQ study will undertake further analysis of metabolome and/or microbiota and/or lymphocyte subpopulation to confirm the results of pilot study.

OBJECTIVES OF THE STUDY

  1. Compare the diet habits and anthropometric measures in bone sarcoma patients at diagnosis with matched controls
  2. Pilot study: in the first 55 pts and their matched 110 healthy voluntary controls will be explored:
  3. the occurrence of altered or more recurrent metabolites in patients' blood compared to controls
  4. different microbiota diversity and composition between patients and case controls
  5. different lymphocytes subpopulations composition.

Bioinformatics analysis will be performed to investigate these objectives

Being tested
EPIC-COS Food Frequency Questionnaire diet Evaluation, Metabolome, Microbiota, Lymphocytes subpopulations
Keywords
Metabolome, Microbiota, Bone sarcoma, Immune profile, Dietary habits
Medical subject headings
Osteosarcoma, Sarcoma, Ewing, Bone Neoplasms, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPIC-COS Food Frequency Questionnaire diet EvaluationOther

    Also called EPIC-FFQ diet Evaluation

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

  • Metabolome, Microbiota, Lymphocytes subpopulationsOther

    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
Study groups in NCT04735289
Study groupRoleWhat they receive
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
Receives: 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
Receives: Other: EPIC-COS Food Frequency Questionnaire diet Evaluation; Other: Metabolome, Microbiota, Lymphocytes subpopulations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At diagnosis, up to 4 years

  2. 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

    Measured: At diagnosis, up to 4 years

  3. 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.

    Measured: At diagnosis, up to 4 years

  4. 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 (%)

    Measured: At diagnosis, up to 4 years

Secondary outcomes (4)

  1. Concentration of blood metabolites - Metabolome

    Concentration of untargeted blood metabolites obtained via mass spectometry SANIST technique from blood of 55 patients and from 110 control subject blood. Metabolome will be analyzed in order to determine if there is an occurrence of altered or more recurrent metabolites in patients' blood compared to controls.

    Measured: At diagnosis, up to 4 years

  2. Microbiota

    Microbiota will be analyzed with S16 method. Microbiota diversity and composition between patients and controls will be analyzed and expressed as alpha and beta diversity

    Measured: At diagnosis, up to 4 years

  3. Concentrations of lymphocytes subpopulation

    Concentrations of (CD3,CD4.CD8,NK) lymphocytes subpopulation will be detected onceat diagnosis before any treatment for sarcoma and they will beexpressed as total number.

    The lymphocytes subpopulation will be measured once at diagnosis in study patients and matched controls.

    Measured: At diagnosis, up to 4 years

  4. Lipid profile and Glucidic profile

    Fatty acids triglycerids(mg/dL), total cholesterol (mg/dL), HDLcholesterol (mg/dL) and LDL cholesterol (mg/dL), glucose (mg/dL) will be measured once in blood at diagnosis in study patients and control subjects

    Measured: At diagnosis, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start10 Mar 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
810 participants (estimated)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04735289
Sponsor's protocol ID
919/2020/Oss/IOR
Acronym
Metabol-Sarc
Status last verified
Aug 2023
First submitted
22 Dec 2020
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28934351

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

    PubMed 25838377

  • 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.

    PubMed 27974040

  • 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.

    PubMed 29558948

  • 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.

    PubMed 32471029

  • 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.

    PubMed 26331920

Questions about this trial

What is this clinical trial studying?

An observational study of Osteosarcoma and Ewing Sarcoma, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alessandra Longhi, MD (+39 (051) 6366-991, alessandra.longhi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diet habits in patients versus case controls measured by EPIC COS FFQ (time frame: At diagnosis, up to 4 years). The study lists 4 primary outcomes in all. 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 NCT04735289, which also lists 6 linked publications.

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 4 Aug 2023.

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