NCT06007794

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
37mo left

Started Feb 2025

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Feb 2025May 2029

First Submitted

Initial submission to the registry

August 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2029

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

August 11, 2023

Last Update Submit

September 10, 2025

Conditions

Keywords

post-cancersarcopeniamedical evaluationmuscle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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 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 the diagnosis of sarcopenia (according to EWSGOP 2019 and BAUMGARTNER)

    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

  • Reproducibility of muscle ultrasound, in a subgroup of patients, inter-observer (n=10 patients)

    through study completion, an average of 9 years

  • +1 more secondary outcomes

Study Arms (1)

JUMP group

EXPERIMENTAL

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.

Other: JUMP group

Interventions

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

JUMP group

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud, rhumatologie

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Cyrille CONFAVREUX, Md,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 23, 2023

Study Start

February 10, 2025

Primary Completion (Estimated)

February 10, 2029

Study Completion (Estimated)

May 10, 2029

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations