Lay Description

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


  • Cancers and Other Neoplasms
  • Mens Health
  • Womens Health
  • Heart, Vascular and Blood
IRB Number
NCT Number registration not required
Open to Enrollment


Eligible Ages
Eligible Genders
Accepts Healthy Volunteers

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

Study Contact

Regulatory Point of Contact
Andrew Brenner
(210) 562-4091

Regulatory Point of Contact
Frances Crawford
(210) 450-5037

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs

Regulatory Point of Contact
Regulatory Staff

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133

Local Recruitment Point of Contact
Morgan Seekatz
(210) 450-1133

Overall Recruitment Point of Contact
Jo Meekins
(210) 450-1000

Principal Investigator
Andrew Brenner