Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy
SPACE2
Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.
2 other identifiers
observational
150
1 country
2
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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedMay 3, 2022
November 1, 2021
8 months
November 29, 2021
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with sarcopenia diagnosed with metastatic cancer.
Sarcopenia is defined for those under 60 years of age by LMSI\<43.1 cm²/m² for men and \<32.7 cm²/m² for women, and for patients over 60 years of age by \<38.6 cm²/m² for men and \<30.7 cm²/m² for women..
At inclusion
Secondary Outcomes (7)
Overall Survival
18 months
Event Free survival
18 months
Progression Free survival
18 months
Unanticipated hospitalization rate
18 months
Statistical relationship between sarcopenia and the PRONOPALL score
18 months
- +2 more secondary outcomes
Study Arms (1)
Standard
Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire
Interventions
Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires
Eligibility Criteria
Patients will be recruited during medical consultations or hospitalization in an onco-hematology service
You may qualify if:
- Patient aged 18 years or older
- 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)
- Patient naive of cancer treatment
- Pathology including performing a CT scan with cuts of the lumbar spine in standard care
- Patient enrolled in social security
- Patient has given his written consent ahead of any specific protocol procedure.
You may not qualify if:
- Minor patient
- Metastatic neurological impairment
- Patient deprived of their liberty, under guardianship or trusteeship
- Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
- Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
- Patient is pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wepromlead
Study Sites (2)
Clinique Victor Hugo/Centre Jean Bernard
Le Mans, 72000, France
Clinique privé du Confluent
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katell LE DU, MD
Private Hospital of Confuent, Nantes
Central Study Contacts
Katell LE DU, MD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 13, 2021
Study Start
June 1, 2022
Primary Completion
February 1, 2023
Study Completion
August 1, 2024
Last Updated
May 3, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share