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Recruiting NCT06007794

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

No phase Interventional Cancer Post-cancer Hematology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JUMP group.
Who it may be relevant to
Registry conditions: Cancer, Post-cancer, Hematology. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • Hôpital Lyon Sud, rhumatologie — Pierre-Bénite

Identifiers

NCT: NCT06007794 · 69HCL23_0368

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗