Exploring Clinical Trial Experiences of People With Leiomyosarcoma


Study First Submitted Date 2022-09-16
Study First Posted Date 2022-09-21
Last Update Posted Date 2023-03-06
Start Month Year October 2023
Primary Completion Month Year October 2024
Verification Month Year September 2022
Verification Date 2022-09-30
Last Update Posted Date 2023-03-06


Sequence: 52071642
Name Leiomyosarcoma
Downcase Name leiomyosarcoma

Id Information

Sequence: 40079515
Id Source org_study_id
Id Value 87688730


Sequence: 79704454
Name leiomyosarcoma
Downcase Name leiomyosarcoma

Design Outcomes

Sequence: 177036714 Sequence: 177036715
Outcome Type primary Outcome Type primary
Measure Number of patients who decide to enroll in an leiomyosarcoma clinical trial Measure Rate of patients who remain in leiomyosarcoma clinical trial to trial completion
Time Frame 3 months Time Frame 12 months

Browse Conditions

Sequence: 193089814 Sequence: 193089815 Sequence: 193089819 Sequence: 193089816 Sequence: 193089817 Sequence: 193089818
Mesh Term Leiomyosarcoma Mesh Term Neoplasms, Muscle Tissue Mesh Term Sarcoma Mesh Term Neoplasms, Connective and Soft Tissue Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms
Downcase Mesh Term leiomyosarcoma Downcase Mesh Term neoplasms, muscle tissue Downcase Mesh Term sarcoma Downcase Mesh Term neoplasms, connective and soft tissue Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48226753
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Power Life Sciences Inc.

Overall Officials

Sequence: 29227061
Role Study Director
Name Michael B Gill
Affiliation Power Life Sciences Inc.

Central Contacts

Sequence: 11987998
Contact Type primary
Name Michael B Gill
Phone 4159004227
Email bask@withpower.com
Role Contact


Sequence: 30707249
Sampling Method Probability Sample
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Population Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.
Criteria 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: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient is pregnant ECOG score of 4
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253929058
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2


Sequence: 30453852
Observational Model Case-Crossover
Time Perspective Prospective

Provided Documents

Sequence: 2575051
Document Type Informed Consent Form
Has Protocol False
Has Icf True
Has Sap False
Document Date 2022-09-16
Url https://ClinicalTrials.gov/ProvidedDocs/79/NCT05548179/ICF_000.pdf

Responsible Parties

Sequence: 28820322
Responsible Party Type Sponsor

Study References

Sequence: 51966437 Sequence: 51966438 Sequence: 51966439
Pmid 34298376 Pmid 24093170 Pmid 35275323
Reference Type background Reference Type background Reference Type background
Citation 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. Citation 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. Citation 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.