OsteosarcomaNCT05535283
Assessing Clinical Trial Experiences of Patients With Osteosarcoma
An observational study of Osteosarcoma, 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 osteosarcoma 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
- Osteosarcoma
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Osteosarcoma patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has been diagnosed with osteosarcoma
- Patient has self-identified as planning to enroll in an interventional clinical trial
- Patient is a minimum of 18 years or older
Who cannot join
- ECOG score of 4
- Patient is pregnant
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Study Investigating The Experiences of Patients In Osteosarcoma 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 osteosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.
People with osteosarcoma who are invited to take part in medical research will benefit from the analysis of the data.
- Conditions
- Osteosarcoma
- Keywords
- osteosarcoma
- Medical subject headings
- Osteosarcoma
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 osteosarcoma clinical trial
Measured: 3 months
Rate of patients who remain in osteosarcoma 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 posted10 Sep 2022
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (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 OsteosarcomaStudies 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
- NCT05535283
- Sponsor's protocol ID
- 83926159
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bielack S, Carrle D, Jost L; ESMO Guidelines Working Group. Osteosarcoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii94-6. doi: 10.1093/annonc/mdn102. No abstract available.
PubMed 18456784Wittig JC, Bickels J, Priebat D, Jelinek J, Kellar-Graney K, Shmookler B, Malawer MM. Osteosarcoma: a multidisciplinary approach to diagnosis and treatment. Am Fam Physician. 2002 Mar 15;65(6):1123-32.
PubMed 11925089Burns L, Perisoglou M. Clinical trials in osteosarcoma treatment: patients' perspective through art. Recent Results Cancer Res. 2009;179:345-61. doi: 10.1007/978-3-540-77960-5_22.
PubMed 19230551
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Investigating The Experiences of Patients In Osteosarcoma Clinical Trials
- ClinicalTrials.gov ID
- NCT05535283
- Acronym / sponsor ID
- 83926159
- Conditions
- Osteosarcoma
- Keywords
- osteosarcoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 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 osteosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.
People with osteosarcoma 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
- Osteosarcoma patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with osteosarcoma
- Patient has self-identified as planning to enroll in an interventional clinical trial
- Patient is a minimum of 18 years or older
Key exclusion criteria (4 listed)
- ECOG score of 4
- Patient is pregnant
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
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 osteosarcoma clinical trial
Time frame: 3 months
Rate of patients who remain in osteosarcoma clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 18456784Bielack S, Carrle D, Jost L; ESMO Guidelines Working Group. Osteosarcoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii94-6. doi: 10.1093/annonc/mdn102. No abstract available.
- Background: PubMed 11925089Wittig JC, Bickels J, Priebat D, Jelinek J, Kellar-Graney K, Shmookler B, Malawer MM. Osteosarcoma: a multidisciplinary approach to diagnosis and treatment. Am Fam Physician. 2002 Mar 15;65(6):1123-32.
- Background: PubMed 19230551Burns L, Perisoglou M. Clinical trials in osteosarcoma treatment: patients' perspective through art. Recent Results Cancer Res. 2009;179:345-61. doi: 10.1007/978-3-540-77960-5_22.
- Individual participant dataSharing planned: Undecided
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Observational Study in Localized Osteosarcoma
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Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma
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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.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, 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: opening soon, as of the sponsor's last update on 2 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
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 osteosarcoma 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 NCT05535283, 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 2 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.