Metastatic CancerSPACE2NCT05154474
Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy
An observational study of Metastatic Cancer and Cancer, Breast, run by Weprom at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Cancer, Breast, Cancer Colon
- What is being tested?
- Standard
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2022to Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited during medical consultations or hospitalization in an onco-hematology service
Who may be able to join
- 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.
Who cannot join
- 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
- History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion
Trial locations and contacts
2 sites in 1 country.
Katell LE DU, MD contact
France2 sites
Clinique Victor Hugo/Centre Jean Bernard
Le Mans, 72000
Julien DOMONT, MD
Julien DOMONT, MD
Clinique privé du Confluent
Nantes, 44000
Katell LE DU, MD
Katell LE DU, MD
About this study
Official title: Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.
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
- Being tested
- Standard
- Keywords
- sarcopenia, quality of life questionnaire, nutrition
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Prostatic Neoplasms, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardOther
Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Standard | Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire Receives: Other: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: At inclusion
Secondary outcomes (7)
Overall Survival
Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.
Measured: 18 months
Event Free survival
Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)
Measured: 18 months
Progression Free survival
Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression
Measured: 18 months
Unanticipated hospitalization rate
Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression
Measured: 18 months
Statistical relationship between sarcopenia and the PRONOPALL score
For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)
Measured: 18 months
Rate of undernourished patients
Calculated according to WHO classification
Measured: 18 months
Rate of patients with sarcopenia at diagnosis across the inclusive population
Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study startJun 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Principal investigator, Private Hospital of Confuent, Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154474
- Sponsor's protocol ID
- WP-2021-03
- Other IDs
- 2021-A01670-41
- Acronym
- SPACE2
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.
- ClinicalTrials.gov ID
- NCT05154474
- Acronym / sponsor ID
- SPACE2 / WP-2021-03
- Conditions
- Metastatic Cancer, Cancer, Breast, Cancer Colon, Cancer, Rectum, Cancer, Lung, Cancer Ovaries
- Keywords
- sarcopenia, quality of life questionnaire, nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard | – | Other: StandardStandard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited during medical consultations or hospitalization in an onco-hematology service
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardStandard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires | Other | Standard |
Primary outcome
Rate of patients with sarcopenia diagnosed with metastatic cancer.
Time frame: At inclusion
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..
7 secondary outcomes
Overall Survival
Time frame: 18 months
Event Free survival
Time frame: 18 months
Progression Free survival
Time frame: 18 months
Unanticipated hospitalization rate
Time frame: 18 months
Statistical relationship between sarcopenia and the PRONOPALL score
Time frame: 18 months
Rate of undernourished patients
Time frame: 18 months
Rate of patients with sarcopenia at diagnosis across the inclusive population
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katell LE DU, MD contact
Katell LE DU, MD principal investigator
Private Hospital of Confuent, Nantes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Cancer, Breast, run by Weprom at 2 sites in France.
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 7 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Magali BALAVOINE (+33(0)241682940, m.balavoine@ilcgroupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with sarcopenia diagnosed with metastatic cancer. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2022.