CancerJUMPresearchIINCT06007794
Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)
A study testing JUMP group in people with Cancer and Post-cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Cancer, Post-cancer, Hematology
- What is being tested?
- JUMP group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to 10 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : 18 to 74 years
- localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy
- patient who benefited from the post-cancer assessment day
Who cannot join
- Active cancer (relapse or new cancer)
- Pregnant or breastfeeding women
- Major cognitive impairment making comprehension and exercise difficult
- Amputation of both lower limbs (for ultrasound)
- Difficulty understanding oral and written French
- Adults under legal protection (guardianship, curatorship or safeguard of justice)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud, rhumatologie
Pierre-Bénite, 69495
Cyrille CONFAVREUX, Md,PhD, +334 78 86 12 31, Cyrille.confavreux@chu-lyon.fr
About this study
Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).
JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.
Read more
This non-interventional research is classified as "research involving human subjects", class 3 .
The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.
- Conditions
- Cancer, Post-cancer, Hematology
- Being tested
- JUMP group
- Keywords
- post-cancer, sarcopenia, medical evaluation, muscle
- Medical subject headings
- Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUMP groupOther
patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment
| Study group | Role | What they receive |
|---|---|---|
| JUMP group | Experimental | This study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day. In addition, an ultrasound of the thigh is performed to measure the size of the quadriceps on 5 different measurements. Receives: Other: JUMP group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA
Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA Mean thickness of the quadriceps (straight femoris) measured by ultrasound compared to the Appendicular Lean Mass/size² in DEXA
Measured: through study completion, an average of 9 years
Secondary outcomes (6)
Correlation between the ultrasound muscle indexes and the scannographic index of the paravertebral muscles (SMI L3, T12 and T7, studied by IA)
Evaluation of the section surface of the rectus femoris in ultrasound, of the adipose infiltration index of the rectus femoris on ultrasound and of the Skeletal Muscle Index (SMI) L3, T12 and T7 in CT (gold standard)
Measured: through study completion, an average of 9 years
Correlation between ultrasound muscle indices and muscle functional tests
Calculation of Functional Indices and questionnaire scores: grip strength, TM6, 30-second sit-to-stand test, SARC-F and IPAQ
Measured: through study completion, an average of 9 years
Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and the diagnosis of sarcopenia (according to EWSGOP 2019 and BAUMGARTNER)
Serum biomarker assays: myostatin, irisin, micro-RNA, osteocalcin, FGF19 and diagnosis of sarcopenia assessed according to Baumgartner and to to EWSGOP 2019 definitions
Measured: through study completion, an average of 9 years
Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and ultrasound, densitometric, scannographic and functional parameters
Serum biomarker assays: myostatin, irisin, micro-RNA, osteocalcin, FGF19, interpretation of images (ultrasound, densitometry, scanner) and results of functional tests
Measured: through study completion, an average of 9 years
Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)
ICC of the thickness of the quadriceps, of its cross-sectional area interobserver (subpopulation of 10 patients)
Measured: through study completion, an average of 9 years
Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients).
ICC of the thickness of the quadriceps, its cross-sectional area intraobserver (subpopulation of 10 patients)
Measured: through study completion, an average of 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Feb 2025
- Primary completion10 Feb 2029 (estimated)
- Study completion10 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007794
- Sponsor's protocol ID
- 69HCL23_0368
- Acronym
- JUMPresearchII
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2023
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)
- ClinicalTrials.gov ID
- NCT06007794
- Acronym / sponsor ID
- JUMPresearchII / 69HCL23_0368
- Conditions
- Cancer, Post-cancer, Hematology
- Keywords
- post-cancer, sarcopenia, medical evaluation, muscle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Feb 2029 (estimated)
- Study completion
- 10 May 2029 (estimated)
- First posted
- 23 Aug 2023 (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.
Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).
JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.
This non-interventional research is classified as "research involving human subjects", class 3 .
The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUMP group | Experimental | Other: JUMP groupThis study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day. In addition, an ultrasound of the thigh is performed to measure the size of the quadriceps on 5 different measurements. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age : 18 to 74 years
- localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy
- patient who benefited from the post-cancer assessment day
Key exclusion criteria (6 listed)
- Active cancer (relapse or new cancer)
- Pregnant or breastfeeding women
- Major cognitive impairment making comprehension and exercise difficult
- Amputation of both lower limbs (for ultrasound)
- Difficulty understanding oral and written French
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 |
|---|---|---|
| JUMP grouppatients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment | Other | JUMP group |
Primary outcome
Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA
Time frame: through study completion, an average of 9 years
Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA Mean thickness of the quadriceps (straight femoris) measured by ultrasound compared to the Appendicular Lean Mass/size² in DEXA
6 secondary outcomes
Correlation between the ultrasound muscle indexes and the scannographic index of the paravertebral muscles (SMI L3, T12 and T7, studied by IA)
Time frame: through study completion, an average of 9 years
Correlation between ultrasound muscle indices and muscle functional tests
Time frame: through study completion, an average of 9 years
Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and the diagnosis of sarcopenia (according to EWSGOP 2019 and BAUMGARTNER)
Time frame: through study completion, an average of 9 years
Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and ultrasound, densitometric, scannographic and functional parameters
Time frame: through study completion, an average of 9 years
Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)
Time frame: through study completion, an average of 9 years
Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients).
Time frame: through study completion, an average of 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUMP group in people with Cancer and Post-cancer, run by Hospices Civils de Lyon 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 3 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyrille CONFAVREUX, Md,PhD (+33 4 78 86 12 31, Cyrille.confavreux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA (time frame: through study completion, an average of 9 years). 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 16 Sep 2025.