ABLATE Registry
CRF #01: To be completed at study entry
Patient initials: ___ ___ ___
F
M
CHECKLIST FOR ENTRY
Study#: ____________
DATE: ___ / ___ / ___
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Inclusion (all answers must be yes)
○Yes ○No Patient is a female, ≥ 50 years of age
○Yes
○Yes
○Yes
○Yes
○Yes
○Yes
○No
○No
○No
○No
○No
○No
The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
The tumor is unicentric and unilateral
The tumor is not involving the skin
Pathology confirms ductal in situ OR infiltrating ductal carcinoma, grade I-III
If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
Patient signs current written informed consent and HIPAA forms
Exclusion (all answers must be no)
○No ○Yes Patient is under 50 years of age
○No
○No
○No
○No
○No
○No
○No
○No
○No
○Yes
○Yes
○Yes
○Yes
○Yes
○Yes
○Yes
○Yes
○Yes
Patient is male
Tumor > 3 cm in diameter
Bilateral malignancy
Tumor involving the skin
Clinically positive lymph nodes
Pathology confirms invasive lobular carcinoma
Breast implants
Less than 2 years disease-free survival from previous breast cancer
Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
“The ABLATE Registry protocol has been discussed with the patient. She fits all of the inclusion criteria
and none of the exclusion criteria. We have discussed the potential side effects, and any potential risks
and/or benefits and the alternatives to study participation. The patient has been allowed to read the entire
consent form and to ask questions. All questions have been answered. The patient has been able to
review all of the information with her family. She has voluntarily agreed to participate. She has been
given a copy of the consent form.”
Signature of person obtaining consent: _________________________________
Date: ___________
Signature of Principal Investigator: ____________________________________
Date: ___________