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

September 10, 2025 updated by: Hospices Civils de Lyon

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 Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Pierre-Bénite, France, 69495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JUMP group
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.
patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Correlation between ultrasound muscle indices and muscle functional tests
Time Frame: through study completion, an average of 9 years
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
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
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
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
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
Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)
Time Frame: through study completion, an average of 9 years
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
Reproducibility of muscle ultrasound, in a subgroup of patients, intra-observer (n=10 patients).
Time Frame: through study completion, an average of 9 years
ICC of the thickness of the quadriceps, its cross-sectional area intraobserver (subpopulation of 10 patients)
through study completion, an average of 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 10, 2029

Study Completion (Estimated)

May 10, 2029

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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