Follicular LymphomaNCT06049485
Assessing the Experience of Patients Undergoing Follicular Lymphoma Clinical Research
An observational study of Follicular Lymphoma, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Historically, participation in medical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Oct 2026
- 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: Patients with follicular lymphoma who are actively considering enrolling in a medical trial for the said condition, but have not yet completed enrollment and randomization phases.
Who may be able to join
- Participant must be 18 years of age or older
- Patient has been diagnosed with follicular lymphoma
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
Who cannot join
- Women of childbearing potential without a negative pregnancy test; or women who are lactating.
- Inability to provide written informed consent
- Patients receiving any other investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Unveiling Follicular Lymphoma Clinical Trials: Analyzing Patient Engagement Patterns and Participation Trends
Historically, participation in medical studies is highly skewed towards particular demographic groups of people.
This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of follicular lymphoma.
The data collected from this study will help improve future outcomes for all follicular lymphoma patients as well as those in under-represented demographic groups.
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma
- Medical subject headings
- Lymphoma, Follicular
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 a follicular lymphoma clinical research
Measured: 3 months
Rate of patients who remain in a follicular lymphoma medical study 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 posted22 Sep 2023
- 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 Follicular LymphomaStudies 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
- NCT06049485
- Sponsor's protocol ID
- 70732724
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gueiderikh A, Ung M, Lazarovici J, Danu A, Ghez D, Saleh K, Dragani M, Noel N, Bigenwald C, Willekens C, Ribrag V, Michot JM, Martin V. Incidence, characteristics, management and outcome of patients with follicular lymphoma with tumor epidural compression, a study on 22 cases. Cancer Radiother. 2023 Sep;27(5):370-375. doi: 10.1016/j.canrad.2023.04.004. Epub 2023 May 6.
PubMed 37156711Friedberg JW, Taylor MD, Cerhan JR, Flowers CR, Dillon H, Farber CM, Rogers ES, Hainsworth JD, Wong EK, Vose JM, Zelenetz AD, Link BK. Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol. 2009 Mar 10;27(8):1202-8. doi: 10.1200/JCO.2008.18.1495. Epub 2009 Feb 9.
PubMed 19204203Ruella M, Filippi AR, Bruna R, Di Russo A, Magni M, Caracciolo D, Passera R, Matteucci P, Di Nicola M, Corradini P, Parvis G, Gini G, Olivieri A, Ladetto M, Ricardi U, Tarella C, Devizzi L. Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):783-91. doi: 10.1016/j.ijrobp.2015.12.019. Epub 2015 Dec 17.
PubMed 26972651
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling Follicular Lymphoma Clinical Trials: Analyzing Patient Engagement Patterns and Participation Trends
- ClinicalTrials.gov ID
- NCT06049485
- Acronym / sponsor ID
- 70732724
- Conditions
- Follicular Lymphoma
- Keywords
- follicular lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- 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
- 22 Sep 2023 (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.
Historically, participation in medical studies is highly skewed towards particular demographic groups of people.
This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of follicular lymphoma.
The data collected from this study will help improve future outcomes for all follicular lymphoma patients as well as those in under-represented demographic groups.
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
- Patients with follicular lymphoma who are actively considering enrolling in a medical trial for the said condition, but have not yet completed enrollment and randomization phases.
Key inclusion criteria (3 listed)
- Participant must be 18 years of age or older
- Patient has been diagnosed with follicular lymphoma
- Patient has access to a home internet connection in order to provide regular updates through the course of the study
Key exclusion criteria (3 listed)
- Women of childbearing potential without a negative pregnancy test; or women who are lactating.
- Inability to provide written informed consent
- Patients receiving any other investigational agents
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 a follicular lymphoma clinical research
Time frame: 3 months
Rate of patients who remain in a follicular lymphoma medical study 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 22 Sep 2023.
- Background: PubMed 37156711Gueiderikh A, Ung M, Lazarovici J, Danu A, Ghez D, Saleh K, Dragani M, Noel N, Bigenwald C, Willekens C, Ribrag V, Michot JM, Martin V. Incidence, characteristics, management and outcome of patients with follicular lymphoma with tumor epidural compression, a study on 22 cases. Cancer Radiother. 2023 Sep;27(5):370-375. doi: 10.1016/j.canrad.2023.04.004. Epub 2023 May 6.
- Background: PubMed 19204203Friedberg JW, Taylor MD, Cerhan JR, Flowers CR, Dillon H, Farber CM, Rogers ES, Hainsworth JD, Wong EK, Vose JM, Zelenetz AD, Link BK. Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol. 2009 Mar 10;27(8):1202-8. doi: 10.1200/JCO.2008.18.1495. Epub 2009 Feb 9.
- Background: PubMed 26972651Ruella M, Filippi AR, Bruna R, Di Russo A, Magni M, Caracciolo D, Passera R, Matteucci P, Di Nicola M, Corradini P, Parvis G, Gini G, Olivieri A, Ladetto M, Ricardi U, Tarella C, Devizzi L. Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):783-91. doi: 10.1016/j.ijrobp.2015.12.019. Epub 2015 Dec 17.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma, run by Power Life Sciences Inc. at 1 site in United States.
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 3 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 22 Sep 2023. 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 United States. 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 Michael B Gill ((415) 900-4227, 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 a follicular lymphoma clinical research (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 NCT06049485, 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 22 Sep 2023.