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ACOSOG-Z1072 Registration Worksheet Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6EC42FC0-2010-95F5-E040-BB89AD432658

Keywords:

Clinical Trial

Registration

Breast Neoplasms

Versions (3)

8/26/12 8/26/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas

Uploaded on:

January 9, 2015

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

English 1

English

Details

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.)

1 forms

StudyEvent: ACOSOG-Z1072 Registration Worksheet
1. 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

Protocol Number

Patient ID

Patient Initials (L F M)

Institution Number

Institution

Are data amended (if data are amended, please circle in red when using paper form)

Yes

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)

Not Applicable (NA)

No (No)

Yes (Yes)

No history of rotational vacuum assisted core biopsies; en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer

Not Applicable (NA)

No (No)

Yes (Yes)

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)

Not Applicable (NA)

No (No)

Yes (Yes)

Tumor enhancement on pre-study MRI

Not Applicable (NA)

No (No)

Yes (Yes)

Tumor with < 25% intraductal components in the aggregate

Not Applicable (NA)

No (No)

Yes (Yes)

No prior or planned neoadjuvant chemotherapy for breast cancer

Not Applicable (NA)

No (No)

Yes (Yes)

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)

N/a (N/A)

No (No)

Yes (Yes)

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)

Not Applicable (NA)

No (No)

Yes (Yes)

Instructions

Patient consented to optional blood sample collection

Yes

Patient's Initial Consent given for blood specimen use for research on the patient's cancer?

Yes

Patient's Initial Consent given for blood specimen use for research unrelated to the patient's cancer?

Yes

Patient's Initial Consent given for tissue specimen use for research on the patient's cancer?

Yes

Patient's Initial Consent given for tissue specimen use for research unrelated to the patient's cancer?

Yes

Patient consented to allow an ACOSOG representative to contact patient in the future to take part in more research

Yes

Description Of Primary Disease

MedDRA Code (10006285 [Breast cancer, NOS])

Primary Site (Tumor Breast)

Histologic Type (check one)

Infiltrating Ductal Carcinoma (Infiltrating ductal)

Other Specify (Other)

Other specify

Nuclear Grade (check one)

Low (Low)

Intermediate (Intermediate)

High (High)

Biopsy Data

Date of core needle biopsy (mm/dd/yyyy)

Needle gauge

Biopsy clip placed at time of biopsy (check one)

Yes

Name of biopsy clip

% Intraductal component (DCIS %)

HER2 results/IHC (check one)

0 (0)

1+ (1+)

2+ (2+)

3+ (3+)

Not Done: C49484 (not done)

HER2 results/FISH (check one)

Amplified (Amplified)

Not Amplified (Not amplified)

Not Done (Not done)

Date (mm/dd/yyyy)

Estrogen/progesterone Data

ER Status (check one)

Negative (Negative)

Positive (Positive)

Unknown (Unknown)

PgR Status (check one)

Negative (Negative)

Positive (Positive)

Unknown (Unknown)

Pregnancy test done (check one)

Yes

Reason pregnancy test not performed (If no check one)

Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)

Other (Other)

Other, specify

Date of Onset of Most Recent Menstrual Period (mm/dd/yyyy)

Date (mm/dd/yyyy)

Not Applicable (Patient is post-menopausal)

Ultrasound/mammogram

Is oncotype analysis planned (check one)

Yes

Is adequate tumor volume present (If yes check one)

Cannot Undergo Cryoablation (Cannot undergo cryoablation)

Need Additional Cores (Need additional cores)

No (No)

Yes (Yes)

Date of Ultrasound (mm/dd/yyyy)

Dimension 2 (Tumor size width cm)

Dimension 3 (Tumor size depth cm)

Date of mammogram (mm/dd/yyyy)

Dimension 1 (Tumor size length cm)

Calcifications (check one)

Absent (Absent)

Present (Present)

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Breast Cancer NCT00723294 Registration - ACOSOG-Z1072 Registration Worksheet - 2919301v1.0

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