ClinicalTrials.gg
Not yet recruitingNCT05548179Updated Mar 6, 2023

Exploring Clinical Trial Experiences of People With Leiomyosarcoma

An observational study in Leiomyosarcoma, sponsored by Power Life Sciences Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Power Life Sciences Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.

02

Conditions studied

  • Leiomyosarcoma

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Keywords

  • leiomyosarcoma
03

In context

Leiomyosarcoma

177 studies on the registry are indexed under Leiomyosarcoma; 35 are open to participants now.

This study's planned enrollment of 500 is above the median of 250 across 15 observational studies indexed under Leiomyosarcoma.

Browse Leiomyosarcoma studies →

Lead sponsor

Power Life Sciences Inc. is the lead sponsor of 111 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.

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

  • Patient has self-identified as planning to enroll in an interventional clinical trial
  • Patient has been diagnosed with leiomyosarcoma
  • Patient is a minimum of 18 years or older

Exclusion criteria

Exclusion Criteria:

  • Patient does not understand, sign, and return consent form
  • Inability to perform regular electronic reporting
  • Patient is pregnant
  • score of 4
Terms in these criteria, in plain language(1)

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.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of patients who decide to enroll in an leiomyosarcoma clinical trial

    Time frame: 3 months

  2. Rate of patients who remain in leiomyosarcoma clinical trial to trial completion

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20. PubMed 34298376 ↗
  • Serrano C, George S. Leiomyosarcoma. Hematol Oncol Clin North Am. 2013 Oct;27(5):957-74. doi: 10.1016/j.hoc.2013.07.002. Epub 2013 Aug 26. PubMed 24093170 ↗
  • Kasper B, D'Ambrosio L, Davis EJ, Ingham M, Broto JM, Trent JC, van Houdt WJ, Van Tine BA. What Clinical Trials Are Needed for Treatment of Leiomyosarcoma? Curr Treat Options Oncol. 2022 Mar;23(3):439-449. doi: 10.1007/s11864-021-00928-y. Epub 2022 Mar 11. PubMed 35275323 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05548179
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Oct 2023 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Oct 2025 (estimated)
Last update
Mar 6, 2023

Study contacts

Michael B Gill
Contact
bask@withpower.com
4159004227
Michael B Gill
study director · Power Life Sciences Inc.

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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