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Clinical Trials/NCT06007794
NCT06007794RecruitingNot Applicable

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

Hospices Civils de Lyon2 sites in 1 country55 target enrollmentStarted: February 10, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
55
Locations
2
Primary Endpoint
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

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Correlation between the ultrasound muscle indexes and the scannographic index of the paravertebral muscles (SMI L3, T12 and T7, studied by IA)(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)(through study completion, an average of 9 years)
  • Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)(through study completion, an average of 9 years)
  • Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients).(through study completion, an average of 9 years)
  • Correlation between ultrasound muscle indices and muscle functional tests(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(through study completion, an average of 9 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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