Clinical trial NCT06007794: Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)
Official title: Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Post-cancer
Hematology
Keywords: post-cancer
sarcopenia
medical evaluation
muscle
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
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
timeFrame: through study completion, an average of 9 years
Secondary outcomes:
measure: Correlation between the ultrasound muscle indexes and the scannographic index of the paravertebral muscles (SMI L3, T12 and T7, studied by IA)
timeFrame: through study completion, an average of 9 years
measure: Correlation between ultrasound muscle indices and muscle functional tests
timeFrame: through study completion, an average of 9 years
measure: Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and the diagnosis of sarcopenia (according to EWSGOP 2019 and BAUMGARTNER)
timeFrame: through study completion, an average of 9 years
measure: Correlation between muscle biological markers (irisin, myostatin, FGF19, TGFb, decarboxylated osteocalcin, microRNA) and ultrasound, densitometric, scannographic and functional parameters
timeFrame: through study completion, an average of 9 years
measure: Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)
timeFrame: through study completion, an average of 9 years
measure: Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients).
timeFrame: through study completion, an average of 9 years
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud, rhumatologie
Study officials:
References: