ClinicalTrials.gg
RecruitingNCT03362801SAMPHYRUpdated Jul 19, 2024

SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

An interventional study of sarcopenia and mobility measurement in Sarcopenia and Bladder Cancer, sponsored by University Hospital, Caen. Recruiting at 3 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2017; still recruiting 9 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 78 studies in Sarcopenia with a site in France — 23 open to participants now, 24 under way, none of them phase 3. Sarcopenia · France.

Planned enrollment
32nd of 53
69 · median 98
Started
2017
with 4 others
No phase
49 of 78
18 open now
Primary completion
2025-07
later than 2 of 23 live
Registered
18th of 78
by date

Among the 78 studies in Sarcopenia with a site in France, this one is the 32nd largest by planned enrollment of the 53 interventional ones that give a count, is one of 5 that started in 2017, is one of 49 with no phase, reaches primary completion later than 2 of the 23 other live ones, and was the 18th registered.

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

Browse Sarcopenia studies →

Open to participants now

23 of the 78 studies in Sarcopenia with a site in France are open now. Recruiting first, the newest first:

17 more — sign in →

All 23 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 78 studies in Sarcopenia with a site in France, or all of them as a file.
02

Study summary

Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy.

According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry).

This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study.

The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter.

Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication.

Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization

03

Conditions studied

  • Sarcopenia
  • Bladder Cancer

Keywords

  • physical activity
  • elderly
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed urothelial bladder carcinoma ( RTUV)

    • indication of radical cystectomy
    • Able, informed and with for the study
    • affiliated to the social security system
    • talking French

Exclusion criteria

Exclusion Criteria:

  • \<6 months

    • other active malignant tumors or other severe concomitant chronic pathologies affecting the general condition of the patient and / or likely to limit compliance with the requirements of the study.
    • treatments incompatible with the study: previous treatment prolonged for more than one month (induces iatrogenic sarcopenia).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (estimated)

Study arms

  • Other
    Sarcopenic

    sarcopenic status the day before cystectomy.

    Diagnostic Test: sarcopenia and mobility measurement

  • Other
    not sarcopenic

    sarcopenic status the day before cystectomy.

    Diagnostic Test: sarcopenia and mobility measurement

Interventions

  • Diagnostic testsarcopenia and mobility measurement

    walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment

06

What researchers measure

Primary outcomes

  1. post-operative morbidity

    evaluated according to Clavien-Dindo classification

    Time frame: at 30 days

  2. post-operative mortality

    Time frame: at 30 days

Secondary outcomes

  1. post-operative complications

    Impact of dependancy (PS / ADL / IADL)

    Time frame: 8 months

  2. post-operative complications

    physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used

    Time frame: 8 months

  3. post-operative complications

    physical performance (PBP)

    Time frame: 8 months

  4. post-operative complications

    fatigue (BFI) Brief Fatigue Inventory questionnaire

    Time frame: 8 months

  5. post-operative complications

    history of fall

    Time frame: 8 months

  6. post-operative complications

    pain (visual analogic scale for pain 0 to 10)

    Time frame: 8 months

  7. post-operative complications

    hours of mobility (actimetry)

    Time frame: 8 months

  8. post-operative complications

    hours of daily rest (actimetry) measured during 3 consecutives days

    Time frame: 8 months

  9. post-operative complications

    Actimetry

    Time frame: 8 months

  10. post-operative complications

    nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )

    Time frame: 8 months

  11. post-operative complications

    cognitive status (normal or not)

    Time frame: 8 months

  12. post-operative complications

    polymedication (≥5 / day)

    Time frame: 8 months

  13. post-operative complications

    comorbidities (updated charlson)

    Time frame: 8 months

  14. post-operative complications

    inappropriate prescriptions (STOPP)

    Time frame: 8 months

  15. impedancemetric value

    Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value

    Time frame: 2 months

  16. sarcopenic status

    evolution of sarcopenic status

    Time frame: between baseline; preoperative and at 6 months post-operative

  17. quality of life scores

    EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)

    Time frame: preoperative and 6-month post-operative

07

Study locations

2 of 3 sites recruiting
08

References and documents

Publications

  • Audisio RA, Bozzetti F, Gennari R, Jaklitsch MT, Koperna T, Longo WE, Wiggers T, Zbar AP. The surgical management of elderly cancer patients; recommendations of the SIOG surgical task force. Eur J Cancer. 2004 May;40(7):926-38. doi: 10.1016/j.ejca.2004.01.016. PubMed 15093567 ↗
  • Huisman MG, van Leeuwen BL, Ugolini G, Montroni I, Spiliotis J, Stabilini C, de'Liguori Carino N, Farinella E, de Bock GH, Audisio RA. "Timed Up & Go": a screening tool for predicting 30-day morbidity in onco-geriatric surgical patients? A multicenter cohort study. PLoS One. 2014 Jan 24;9(1):e86863. doi: 10.1371/journal.pone.0086863. eCollection 2014. Erratum In: PLoS One. 2014;9(7):e103907. de'Liguori Carino, Nicola [corrected to Carino, Nicola de'Liguori]. PLoS One. 2016 Jan 26;11(1):e0147993. doi: 10.1371/journal.pone.0147993. PubMed 24475186 ↗
  • Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13. PubMed 26882087 ↗
  • Psutka SP, Carrasco A, Schmit GD, Moynagh MR, Boorjian SA, Frank I, Stewart SB, Thapa P, Tarrell RF, Cheville JC, Tollefson MK. Sarcopenia in patients with bladder cancer undergoing radical cystectomy: impact on cancer-specific and all-cause mortality. Cancer. 2014 Sep 15;120(18):2910-8. doi: 10.1002/cncr.28798. Epub 2014 May 19. PubMed 24840856 ↗
  • Smith AB, Deal AM, Yu H, Boyd B, Matthews J, Wallen EM, Pruthi RS, Woods ME, Muss H, Nielsen ME. Sarcopenia as a predictor of complications and survival following radical cystectomy. J Urol. 2014 Jun;191(6):1714-20. doi: 10.1016/j.juro.2013.12.047. Epub 2014 Jan 11. PubMed 24423437 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Jul 2025, 92 months after the start.

Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 92 months is above that.

Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2017
First posted
Dec 5, 2017
StartActual
Oct 30, 2017
Primary completionEst.
Jul 1, 2025
CompletionEst.
Feb 1, 2026
Last update
Jul 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03362801
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Oct 30, 2017
Primary completion
Jul 1, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Jul 19, 2024

Study contacts

françois fournel
Contact
fournel-f@chu-caen.fr
+33231065488
helene legros
Contact
legros-h@chu-caen.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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