Clinical trial NCT04499534: BRCA1/2 Flu Vaccine
Official title: Influenza Vaccine Study in BRCA1 or BRCA2 Carriers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: BRCA1 Mutation
BRCA2 Mutation
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 25 years and older, seen at Cancer Risk Evaluation Program (CREP) in the Perelman Center for Advanced Medicine with BRCA1 or BRCA2 mutation.

Brief summary: To evaluate immune function in BRCA1/2 mutation carriers without cancer, specifically to determine whether immune function in healthy individuals with germline loss of function BRCA1/2 mutations, impacts overall immune health and fitness.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Over age 25
* BRCA1 or BRCA2 pathogenic or likely pathogenic mutation
* No personal cancer history apart from non melanoma skin cancer, localized thyroid cancer, in situ cancers of any type
* Participants must sign the informed consent form

Exclusion Criteria:

* Are allergic to influenza vaccination
* Have received influenza vaccination within the past 6 months
* Require prednisone, methotrexate, or other immunosuppressing medications
* Have HIV infection
* Have a history of solid organ tumor or bone marrow transplant
* Require combination immunotherapy;
* Are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

Primary outcomes:
measure: To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination
timeFrame: 2 years
Secondary outcomes:
measure: Exploratory analysis- phenotypic evaluation of B cell
timeFrame: 2 years
measure: Exploratory analysis - transcriptional evaluation
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Susan Domchek, MD
role: PRINCIPAL_INVESTIGATOR
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