LeiomyosarcomaNCT05548179
Exploring Clinical Trial Experiences of People With Leiomyosarcoma
An observational study of Leiomyosarcoma, run by Power Life Sciences Inc..
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leiomyosarcoma
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- 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
Who cannot join
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
- ECOG score of 4
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An In Depth Study Investigating The Experiences of Patients In Leiomyosarcoma Clinical Trials
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.
- Conditions
- Leiomyosarcoma
- Keywords
- leiomyosarcoma
- Medical subject headings
- Leiomyosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in an leiomyosarcoma clinical trial
Measured: 3 months
Rate of patients who remain in leiomyosarcoma clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548179
- Sponsor's protocol ID
- 87688730
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 34298376Serrano 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 24093170Kasper 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 at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Depth Study Investigating The Experiences of Patients In Leiomyosarcoma Clinical Trials
- ClinicalTrials.gov ID
- NCT05548179
- Acronym / sponsor ID
- 87688730
- Conditions
- Leiomyosarcoma
- Keywords
- leiomyosarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
- ECOG score of 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to enroll in an leiomyosarcoma clinical trial
Time frame: 3 months
Rate of patients who remain in leiomyosarcoma clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 34298376Kantidakis 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.
- Background: PubMed 24093170Serrano 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.
- Background: PubMed 35275323Kasper 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyosarcoma, run by Power Life Sciences Inc..
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 3 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to enroll in an leiomyosarcoma clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT05548179, which also lists 3 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 6 Mar 2023.