AzTrials
AzTrials

Sarcoma1206NCT06282237

Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

An observational study of Sarcoma, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sarcoma
What is being tested?
survey
How many people
13 participants
Where
1 siteItaly
Study dates
1 Jul 2023to 1 Jul 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment.

Who may be able to join

  • Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.

Who cannot join

  • Patients with recurrent tumors;
  • patients with metastatic disease;
  • patients with palliative surgery;
  • patients with amputations.

Trial locations and contacts

1 site in 1 country.

Sergio Valeri contact

06225411626

s.valeri@policlinicocampus.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Campus Biomedico

    Roma, 00128

    Sergio Valeri, MD, 06225411626, s.valeri@policlinicocampus.it

    Recruiting

Other trials in Italy

About this study

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

Read more
  • Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;
  • Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;
  • Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

  1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);
  • The change in walking performance before and after the rehabilitation treatment.
Conditions
Sarcoma
Being tested
survey
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surveyOther

    Quality of life survey and motor performace survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in the Toronto Extremity Salvage Score (TESS)

    a change in the TESS greater than 7 points

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Secondary outcomes (6)

  1. Pain evaluation

    Brief Pain Questionnaire

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

  2. Motor performance evaluation

    Musculoskeletal Tumor Society Rating Scale

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

  3. Evaluation of Quality of Life

    Quality-of-Life Questionnaire (QLQ)-C30

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

  4. Pain evaluation

    Douleur Neuropathique en 4 Questions

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

  5. Pain evaluation

    Leeds Assessment of Neuropathic Symptoms and Signs Scale

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

  6. Evaluation of Quality of Life

    Short Form Health Survey 36

    Measured: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
13 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282237
Sponsor's protocol ID
2022.143
Acronym
1206
Status last verified
Feb 2024
First submitted
29 Jan 2024
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.

    PubMed 11323136

  • Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

    PubMed 10201543

  • Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.

    PubMed 15030944

  • Cacchio A, De Blasis E, Necozione S, Rosa F, Riddle DL, di Orio F, De Blasis D, Santilli V. The Italian version of the lower extremity functional scale was reliable, valid, and responsive. J Clin Epidemiol. 2010 May;63(5):550-7. doi: 10.1016/j.jclinepi.2009.08.001. Epub 2009 Nov 12.

    PubMed 19913388

  • Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.

    PubMed 8826494

  • Davis AM, Wright JG, Williams JI, Bombardier C, Griffin A, Bell RS. Development of a measure of physical function for patients with bone and soft tissue sarcoma. Qual Life Res. 1996 Oct;5(5):508-16. doi: 10.1007/BF00540024.

    PubMed 8973131

  • den Hollander D, Van der Graaf WTA, Fiore M, Kasper B, Singer S, Desar IME, Husson O. Unravelling the heterogeneity of soft tissue and bone sarcoma patients' health-related quality of life: a systematic literature review with focus on tumour location. ESMO Open. 2020 Oct;5(5):e000914. doi: 10.1136/esmoopen-2020-000914.

    PubMed 33082266

  • Gerrand C, Furtado S. Issues of Survivorship and Rehabilitation in Soft Tissue Sarcoma. Clin Oncol (R Coll Radiol). 2017 Aug;29(8):538-545. doi: 10.1016/j.clon.2017.04.001. Epub 2017 Apr 22.

    PubMed 28442210

  • Kask G, Repo JP, Tukiainen EJ, Blomqvist C, Barner-Rasmussen I. Soft Tissue Sarcoma of Lower Extremity: Functional Outcome and Quality of Life. Ann Surg Oncol. 2021 Oct;28(11):6892-6905. doi: 10.1245/s10434-021-09774-6. Epub 2021 Mar 19.

    PubMed 33740199

  • Kask G, Barner-Rasmussen I, Repo JP, Kjaldman M, Kilk K, Blomqvist C, Tukiainen EJ. Functional Outcome Measurement in Patients with Lower-Extremity Soft Tissue Sarcoma: A Systematic Literature Review. Ann Surg Oncol. 2019 Dec;26(13):4707-4722. doi: 10.1245/s10434-019-07698-w. Epub 2019 Aug 12.

    PubMed 31407171

  • Ogura K, Uehara K, Akiyama T, Shinoda Y, Iwata S, Tsukushi S, Kobayashi E, Hirose T, Yonemoto T, Endo M, Tanzawa Y, Nakatani F, Kawano H, Tanaka S, Kawai A. Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma. J Orthop Sci. 2020 Mar;25(2):315-318. doi: 10.1016/j.jos.2019.03.022. Epub 2019 Apr 16.

    PubMed 31000377

  • Padua L, Briani C, Jann S, Nobile-Orazio E, Pazzaglia C, Morini A, Mondelli M, Ciaramitaro P, Cavaletti G, Cocito D, Fazio R, Santoro L, Galeotti F, Carpo M, Plasmati R, Benedetti L, Schenone A, Marchettini P, Cruccu G. Validation of the Italian version of the Neuropathic Pain Symptom Inventory in peripheral nervous system diseases. Neurol Sci. 2009 Apr;30(2):99-106. doi: 10.1007/s10072-009-0025-y. Epub 2009 Feb 6.

    PubMed 19198756

  • Sartorio F, Moroso M, Vercelli S, Bravini E, Medina ME, Spalek R, Ferriero G. [CROSS-CULTURAL ADAPTATION, AND VALIDITY OF THE ITALIAN VERSION OF THE UPPER LiMB FUNCTIONAL INDEx (ULFI-I)]. G Ital Med Lav Ergon. 2015 Apr-Jun;37(2):115-9. Italian.

    PubMed 26364445

  • Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.

    PubMed 31957034

  • Van Seventer R, Vos C, Meerding W, Mear I, Le Gal M, Bouhassira D, Huygen FJ. Linguistic validation of the DN4 for use in international studies. Eur J Pain. 2010 Jan;14(1):58-63. doi: 10.1016/j.ejpain.2009.01.005. Epub 2009 Mar 17.

    PubMed 19282208

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoma, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sergio Valeri (06225411626, s.valeri@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in the Toronto Extremity Salvage Score (TESS) (time frame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06282237, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in