Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

NCT ID: NCT05154474

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-08-31

Brief Summary

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

Conditions

Metastatic Cancer; Cancer, Breast; Cancer Colon; Cancer, Rectum; Cancer, Lung; Cancer Ovaries; Cancer Prostate; Cancer, Kidney; Cancer Pancreas; Myeloma; Myelodysplasia; Leukemia, Myeloid, Acute; Leukemia,Myeloid, Chronic; Leukemia, Lymphocytic, Acute; Leukemia, Lymphocytic, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard

Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire

Standard

Intervention Type: OTHER

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Interventions

Standard

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient aged 18 years or older

2. Patient with solid cancer diagnosed with metastatic disease,or hematological disease requiring treatment (myeloma, lymphoma, high-risk myelodysplasia, acute or chronic myeloid leukemia, acute and chronic lymphoid leukemia)

3. Patient naive of cancer treatment

4. Pathology including performing a CT scan with cuts of the lumbar spine in standard care

5. Patient enrolled in social security

6. Patient has given his written consent ahead of any specific protocol procedure.

Exclusion Criteria

1. Minor patient

2. Metastatic neurological impairment

3. Patient deprived of their liberty, under guardianship or trusteeship

4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol

5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons

6. Patient is pregnant

7. History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weprom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katell LE DU, MD

Role: PRINCIPAL_INVESTIGATOR

Private Hospital of Confuent, Nantes

Locations

Clinique Victor Hugo/Centre Jean Bernard

Le Mans, , France

Clinique privé du Confluent

Nantes, , France

Countries

France

Central Contacts

Magali BALAVOINE

Role: CONTACT

m.balavoine@ilcgroupe.fr

+33(0)241682940

Katell LE DU, MD

Role: CONTACT

Facility Contacts

Julien DOMONT, MD

Role: primary

Katell LE DU, MD

Role: primary

Other Identifiers

2021-A01670-41

Identifier Type: OTHER

Identifier Source: secondary_id

WP-2021-03

Identifier Type: -

Identifier Source: org_study_id