ACOSOG-Z1072 Registration Worksheet Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer Source Form: NCI FormBuilder:

  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

Instructions: Mark the appropriate line for each Inclusion and Exclusion Criterion below. Each criterion must be answered and all protocol criteria must be met prior to registering the patient into this study. (If any items are marked "N/A" [not applicable], patient is still eligible to be registered into the study.) NOTE: Each criterion must be addressed and documented in the patient's medical record.)

Header Module
Are data amended (if data are amended, please circle in red when using paper form)
Eligibility Criteria
Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy (NOTE: Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion are NOT eligible. Patients with contralateral disease will remain eligible. NOTE: Results of ER, PR, HER-2/neu and Oncotye DX if needed must be obtained on pre-registration needle core biopsy material. See Testing Guidelines Section 3.1)
No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
Tumor size <= 2.0 cm in greatest diameter (Specifically, the tumor must measure <=2.0 cm in the axis parallel to the treatment probe and <=1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by mammogram, ultrasound or MRI will be used to determine eligibility)
Tumor enhancement on pre-study MRI
Tumor with < 25% intraductal components in the aggregate
No prior or planned neoadjuvant chemotherapy for breast cancer
Non-pregnant and non-lactating (Patients of childbearing potential must have a negative serum or urine pregnancy test. Note: Peri-menopausal women must be mernorrheic for >12 months to be considered not of childbearing potential)
Adequate breast size for safe cryoablation (Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation)
Patient consented to optional blood sample collection
Patient's Initial Consent given for blood specimen use for research on the patient's cancer?
Patient's Initial Consent given for blood specimen use for research unrelated to the patient's cancer?
Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?
Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?
Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research
Description Of Primary Disease
Histologic Type (check one)
Nuclear Grade (check one)
Biopsy Data
Biopsy clip placed at time of biopsy (check one)
HER2 results/IHC (check one)
HER2 results/FISH (check one)
Estrogen/progesterone Data
ER Status (check one)
PgR Status (check one)
Pregnancy test done (check one)
Reason pregnancy test not performed (If no check one)
Is oncotype analysis planned (check one)
Is adequate tumor volume present (If yes check one)
Calcifications (check one)

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