Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

Cancer Clinical Trial

— JUMPresearchII  

Official title:

Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06007794
• Other study ID #: 69HCL23_0368
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2028

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: Cyrille CONFAVREUX, Md,PhD
• Phone: +33 4 78 86 12 31
• Email: Cyrille.confavreux[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cancer
• Hematology

Intervention

Other:
• JUMP group
patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment

Locations

Country	Name	City	State
France	Hôpital Lyon Sud, rhumatologie	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 9 years
Secondary	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)	through study completion, an average of 9 years
Secondary	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	through study completion, an average of 9 years
Secondary	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	through study completion, an average of 9 years
Secondary	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	through study completion, an average of 9 years
Secondary	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)	through study completion, an average of 9 years
Secondary	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)	through study completion, an average of 9 years