Clinical trial NCT06070246: Navigating the Clinical Research Process for Lymphoma
Official title: Gaining Insights Into Patient Involvement Patterns and Trends in Participation in Lymphoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma
Keywords: Lymphoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lymphoma patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of lymphoma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future lymphoma patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of lymphoma
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a lymphoma clinical research.
timeFrame: 3 months
measure: Number of lymphoma study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: He X, Xu P, Wang X, Jiang S, Gong D, Wu N. The association of gene rearrangement and lymphoma diagnosis: A prospective observational study. Medicine (Baltimore). 2020 Jun 12;99(24):e20733. doi: 10.1097/MD.0000000000020733.
citation: Dhir V, Maganti M, Rozenberg D, Kukreti V, Kuruvilla J, Crump M, Prica A. Predicting the Risks of Aggressive-Intent Chemotherapy Toxicity in Older Patients With Lymphoma: A Prospective Observational Pilot Study. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e792-e803. doi: 10.1016/j.clml.2022.04.011. Epub 2022 Apr 29.
citation: Tanaka R, Kaburaki T, Taoka K, Karakawa A, Tsuji H, Nishikawa M, Yatomi Y, Shinozaki-Ushiku A, Ushiku T, Araki F. More Accurate Diagnosis of Vitreoretinal Lymphoma Using a Combination of Diagnostic Test Results: A Prospective Observational Study. Ocul Immunol Inflamm. 2022 Aug;30(6):1354-1360. doi: 10.1080/09273948.2021.1873394. Epub 2021 Apr 1.