Metastatic CancerSPACENCT04714203
Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients
An observational study of Metastatic Cancer, run by Weprom at 1 site in France.
Trial summary
Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- sarcopenia assessment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 31 Aug 2019
- 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: The population will include all patients diagnosed with metastatic disease (either present at diagnosis or occurring after an initially localized cancer).
Who may be able to join
- age> 18 years old,
- patient with solid cancer diagnosed with metastatic disease,
- having had a biological assessment and a CT scan in the month preceding the medical consultation,
- and whose prognosis is considered palliative
Who cannot join
- age <18 years old,
- adults under guardianship measure,
- pregnancy or breastfeeding in progress,
- malignant hemopathies,
- metastatic germ cell tumors,
- non-metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.
Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).
Read more
The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).
Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).
The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.
The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.
- Conditions
- Metastatic Cancer
- Being tested
- sarcopenia assessment
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopenia assessmentOther
evaluation of sarcopenia status
| Study group | Role | What they receive |
|---|---|---|
| cohort | Sarcopenia assessment Receives: Other: sarcopenia assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia
Number of patients with sarcopenia in the numerator out of the total number of patients included in the study in the denominator
Measured: 1 month
Secondary outcomes (5)
Prevalence of undernutrition
Number of patients with nutritional disorders at inclusion in numerator out of the number of patients followed in denominator
Measured: 1 month
Overall survival
Time between the inclusion date and the date of death regardless of the cause or the date of the latest news if the patient is censored
Measured: 6 months
Progression free survival
Time between the inclusion date and the date of the first examination showing Time disease progression or the date of death if the patient is deceased or the date of the latest news if the patient is censored
Measured: 6 months
Event free survival
Time between the date of inclusion and the date of the first event identified or the date of death if the patient is deceased or the date of the latest news if the patient is censored
Measured: 6 months
Correlation between PRONOPALL score and sarcopenia
Calculation of PRONOPALL score (high score corresponds to a worse situation)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jun 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Principal investigator, Clinique Victor Hugo/Centre Jean Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714203
- Sponsor's protocol ID
- WP-2019-04
- Acronym
- SPACE
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 19 Jan 2021
- 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 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients
- ClinicalTrials.gov ID
- NCT04714203
- Acronym / sponsor ID
- SPACE / WP-2019-04
- Conditions
- Metastatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 19 Jan 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.
Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.
Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).
The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).
Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).
The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.
The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Other: sarcopenia assessmentSarcopenia assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include all patients diagnosed with metastatic disease (either present at diagnosis or occurring after an initially localized cancer).
Key inclusion criteria (4 listed)
- age> 18 years old,
- patient with solid cancer diagnosed with metastatic disease,
- having had a biological assessment and a CT scan in the month preceding the medical consultation,
- and whose prognosis is considered palliative
Key exclusion criteria (6 listed)
- age <18 years old,
- adults under guardianship measure,
- pregnancy or breastfeeding in progress,
- malignant hemopathies,
- metastatic germ cell tumors,
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 |
|---|---|---|
| sarcopenia assessmentevaluation of sarcopenia status | Other | cohort |
Primary outcome
Prevalence of sarcopenia
Time frame: 1 month
Number of patients with sarcopenia in the numerator out of the total number of patients included in the study in the denominator
5 secondary outcomes
Prevalence of undernutrition
Time frame: 1 month
Overall survival
Time frame: 6 months
Progression free survival
Time frame: 6 months
Event free survival
Time frame: 6 months
Correlation between PRONOPALL score and sarcopenia
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- 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 principal investigator
Clinique Victor Hugo/Centre Jean Bernard
1 site 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, run by Weprom at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sarcopenia (time frame: 1 month). 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 19 Jan 2021.