Purpose

Evaluation of the Clinical Performance of the PAXgene Blood ccfDNA Tube in Comparison to the BD Vacutainer K2EDTA Tube Using the therascreen PIK3CA RGQ PCR Kit

Category

IRB Number
20210280HU
NCT Number
-
Open to Enrollment
Yes
Sponsor
-



Study Contact

Local Recruitment Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu

Overall Recruitment Point of Contact
Jo Meekins
(210) 450-1000
meekins@uthscsa.edu

Principal Investigator
Andrew Brenner

Regulatory Point of Contact
Andrew Brenner
(210) 562-4091
brennera@uthscsa.edu

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
18-99
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    1. Have a histologically and/or cytologically-confirmed diagnosis of ER+ and/or

    2. If tumor has been surgically removed, subject must have radiological or other

    objective evidence of disease recurrence or metastasis present at time of enrollment.

    3. Must consent to the collection of the required volume of blood (~30mL), collected via a routine venipuncture.

Exclusion Criteria

    1. If no evidence of disease after surgical removal of the tumor.

    2. Known to be pregnant at time of enrollment (self-reported)

    3. Not able or unwilling to comply with study procedures.

    4. Any other conditions that, in the opinion of the Investigator, would exclude the subject from the study.


Study Design

Arm Groups