SarcopeniaA15-10NCT02811666
Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
A study testing Assessment of sarcopenia by CT-Scan and hand gauge in people with Sarcopenia and Malnutrition, run by CHU de Reims at 1 site in France.
Trial summary
Sarcopenia (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Malnutrition, Pancreatic Cancer
- What is being tested?
- Assessment of sarcopenia by CT-Scan and hand gauge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Nov 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients treated in the our digestive surgery department during the inclusion phase for the surgical curative treatment of liver (primary or secondary) and pancreatic cancer
- Patients over 18 years
- Patients who agreed to participate in the study
- The patients insured by French health care
Who cannot join
- Patients treated by radio-frequency
- Patients operated for extrahepatic cholangiocarcinoma , cancer of the papilla of Vater or the gall-bladder
- Patients with primary peritoneal cancer
- Patients with palliative surgery without resection
- Patients protected by law
- Minor patients
Trial locations and contacts
1 site in 1 country.
Yohann RENARD contact
France1 site
Chu de Reims
Reims, France, 51092
Yohann RENARD, yrenard@chu-reims.fr
About this study
Sarcopenia (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on postoperative course in digestive oncology. The search for sarcopenia, complementary nutritional status, is now a source of great interest with 62 ongoing projects in the United States.
The first objective of this study is to evaluate the impact of preoperative sarcopenia on 30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative sarcopenia on the long term outcomes (12 months) on the same patients.
Read the detailed description
In this interventional, intent-to-treat, single-center cohort, prospective study, sarcopenia will be evaluated by the decrease in muscle surface (assessed by CT-Scan) associated with a decrease in muscle strength (assessed by hand gauge). Preoperative evaluation will also include nutritional status by physical examination and laboratory tests, and many nutritional questionnaires. The same data (including sarcopenia, laboratory tests and nutritional evaluation) will be collected at 7 days, 30 days and 12 months, as well as the morbidity and mortality. Statistical tests might evaluate if sarcopenia may be an independent factor of morbidity and mortality among these patients.
- Conditions
- Sarcopenia, Malnutrition, Pancreatic Cancer, Liver Cancer
- Being tested
- Assessment of sarcopenia by CT-Scan, hand gauge
- Medical subject headings
- Sarcopenia, Malnutrition, Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of sarcopenia by CT-ScanDevice
hand gaugeDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients operated for liver or pancreas cancer | Experimental | Not described Receives: Device: Assessment of sarcopenia by CT-Scan; Device: hand gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle surface using CT-Scan
Measured: up to12th month postoperatively
muscle strength using a hand gauge
Measured: up to12th month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811666
- Sponsor's protocol ID
- PA16063
- Acronym
- A15-10
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Sarcopenia on Morbidity and Mortality in Patients Operated on From Digestive Cancers
- ClinicalTrials.gov ID
- NCT02811666
- Acronym / sponsor ID
- A15-10 / PA16063
- Conditions
- Sarcopenia, Malnutrition, Pancreatic Cancer, Liver Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Jun 2016 (estimated)
- 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 (loss of muscle mass and function) can be observed at any age and results of multiple factors (age, activity, inflammatory factors, nutritional status...). It deeply impacts the physical performance and the basal metabolism, and induces cardiovascular disorders, dyslipidemia, and diabetes. Sarcopenia appears like an independent factor decreasing the quality of life, exacerbating the toxicity of chemotherapy and increasing mortality for gastrointestinal cancer. However, few studies have demonstrated his impact on postoperative course in digestive oncology. The search for sarcopenia, complementary nutritional status, is now a source of great interest with 62 ongoing projects in the United States.
The first objective of this study is to evaluate the impact of preoperative sarcopenia on 30-days morbidity and mortality of patients operated on from poor prognosis gastrointestinal cancer (liver and pancreas). The second objective is to evaluate the impact of preoperative sarcopenia on the long term outcomes (12 months) on the same patients.
Detailed description
In this interventional, intent-to-treat, single-center cohort, prospective study, sarcopenia will be evaluated by the decrease in muscle surface (assessed by CT-Scan) associated with a decrease in muscle strength (assessed by hand gauge). Preoperative evaluation will also include nutritional status by physical examination and laboratory tests, and many nutritional questionnaires. The same data (including sarcopenia, laboratory tests and nutritional evaluation) will be collected at 7 days, 30 days and 12 months, as well as the morbidity and mortality. Statistical tests might evaluate if sarcopenia may be an independent factor of morbidity and mortality among these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated for liver or pancreas cancer | Experimental | Device: Assessment of sarcopenia by CT-Scan, Device: hand gauge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients treated in the our digestive surgery department during the inclusion phase for the surgical curative treatment of liver (primary or secondary) and pancreatic cancer
- Patients over 18 years
- Patients who agreed to participate in the study
- The patients insured by French health care
Key exclusion criteria (6 listed)
- Patients treated by radio-frequency
- Patients operated for extrahepatic cholangiocarcinoma , cancer of the papilla of Vater or the gall-bladder
- Patients with primary peritoneal cancer
- Patients with palliative surgery without resection
- Patients protected by law
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 |
|---|---|---|
| Assessment of sarcopenia by CT-Scan | Device | Patients operated for liver or pancreas cancer |
| hand gauge | Device | Patients operated for liver or pancreas cancer |
Primary outcome
muscle surface using CT-Scan
Time frame: up to12th month postoperatively
muscle strength using a hand gauge
Time frame: up to12th month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
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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.
Yohann RENARD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of sarcopenia by CT-Scan and hand gauge in people with Sarcopenia and Malnutrition, run by CHU de Reims 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: status not confirmed, as of the sponsor's last update on 23 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohann RENARD (yrenard@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle surface using CT-Scan (time frame: up to12th month postoperatively). The study lists 2 primary outcomes in all. 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 23 Jun 2016.