Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM) (PRISMM)
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|ClinicalTrials.gov Identifier: NCT04447651|
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : November 27, 2020
|Condition or disease||Intervention/treatment|
|Metastatic Breast Cancer SF3B1 Gene Mutation Spliceosome Mutation||Other: Recommendation for treatment with immunotherapy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||A Remote-Directed "Virtual" Clinical Trial in Metastatic Breast Cancer to Determine Feasibility of Evaluating Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)|
|Actual Study Start Date :||September 17, 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2025|
Patients with SF3B1 mutation
Metastatic breast cancer patients that have a SF3B1 mutation
Other: Recommendation for treatment with immunotherapy
Patients with a SF3B1 mutation will be reviewed by the molecular tumor board and treatment recommendations will be given to the patient's treating oncologist.
- Feasibility of study as assessed by completion of study accrual within study time frame [ Time Frame: 2 years ]To evaluate the feasibility of conducting a prospective study using online recruitment tools to involve patients and physicians who are not usually served by clinical trials. Measured by enrolling 60 patients over 2 years.
- Feasibility of study as assessed by physician responses [ Time Frame: 1 year ]To evaluate the feasibility of conducting a prospective study using online recruitment tools to involve patients and physicians who are not usually served by clinical trials. Measured by obtaining responses from 80 percent of physicians within 1 year of enrollment.
- Feasibility of case review as assessed by time to issuance of recommendations [ Time Frame: 4 weeks from consent ]To evaluate the feasibility of real-time case review by a centralized specialized cancer tumor board to assist in therapeutic decision making. Measured by time (days) to issuance of recommendations within 4 weeks from consent for at least 80 percent of patients.
Biospecimen Retention: Samples With DNA
Blood samples will be collected to:
- Evaluate whether mutations detected in tumor tissue using various Clinical Laboratory Improvement Amendments (CLIA)-certified next-generation sequencing assays correlate with those found in plasma tumor DNA (ptDNA).
- To evaluate changes in ptDNA from baseline to 3 months in patients with spliceosome mutations receiving immune checkpoint inhibitors (ICI)
- To evaluate changes in circulating immune cells (PBMCs) from baseline to 3 months in patients with spliceosome mutations receiving ICI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447651
|Contact: Hopkins Breast Trials||410-614-1361||PRISMM@jhmi.edu|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21236|
|Principal Investigator:||Cesar Santa-Maria, MD||Johns Hopkins University|