Form:	BRS-I Clinical v2.3

CDE ID	CDE Description
* 1063	Site Participant ID (Go To: 422)
* 422	EDRN Site ID (Go To: 423)
* 423	EDRN Protocol ID (Go To: 929)
* 929	EDRN Staff ID of the person who collected the data: (Go To: 1219)
* 1219	Date of contact (MM/DD/YYYY): (Go To: 4878)
* 4878	Participant cohort (timing) (Go To: 955)
	Permissible Values (value): Prospective (1) (Go To: 1054)
	Retrospective (2)
* 1054	Specimen collection date (MM/DD/YYYY): (Go To: 955)
* 955	Date of imaging test (MM/DD/YYYY): (Go To: 3651)
* 3651	Interpretation (BI-RADS), overall (Go To: 2591)
	Permissible Values (value): Category 0: Needs additional imaging (0)
	Category 1: Negative (1)
	Category 2: Benign (2)
	Category 3: Probably benign (3)
	Category 4: Suspicious (4)
	Category 5: Highly suggestive of malignancy (5)
	Category 6: Known biopsy-proven malignancy (6)
	Category 4A: Low suspicion for malignancy (41)
	Category 4B: Moderate suspicion for malignancy (42)
	Category 4C: High suspicion for malignancy (43)
	Unknown (99)
* 2591	Mode of detection: (Go To: 1641)
	Permissible Values (value): Ultrasound (1)
	Mammography (2) (Go To: 4739)
	MRI (4)
	Other (95)
	Unknown (99)
* 4739	Is the image available? (Go To: 1641)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 1641	Breast Density Score (BDS) for right breast: (Go To: 2601)
	Permissible Values (value): Category 1 (1)
	Category 2 (2)
	Category 3 (3)
	Category 4 (4)
	Unknown (99)
* 2601	Mode of detection for right breast density score: (Go To: 1642)
	Permissible Values (value): Ultrasound (1)
	Mammography (2)
	MRI (4)
	Other (95)
	Unknown (99)
* 1642	Breast Density Score (BDS) for left breast: (Go To: 2599)
	Permissible Values (value): Category 1 (1)
	Category 2 (2)
	Category 3 (3)
	Category 4 (4)
	Unknown (99)
* 2599	Mode of detection for left breast density score: (Go To: 2934)
	Permissible Values (value): Ultrasound (1)
	Mammography (2)
	MRI (4)
	Other (95)
	Unknown (99)
* 2934	Was the biopsy performed? (Go To: 2158)
	Permissible Values (value): No (0) (Go To: 4648)
	Yes (1)
	Unknown (99) (Go To: 4648)
* 4648	Is the participant on active surveillance? (Go To: 1097)
	Permissible Values (value): No (0) (Go To: 2602)
	Yes (1)
	Unknown (99)
* 2158	Number of specimens: (Go To: 3200)
* 3200	Line number or identifier (system-generated): (Go To: 2603)
* 2603	Study group: (Go To: 2638)
	Permissible Values (value): Normal (0) (Go To: 4762)
	Benign disease control: non-proliferative (2) (Go To: 4762)
	Benign disease control: proliferative (1) (Go To: 4762)
	Case: DCIS (3)
	Case: LCIS (5)
	Case: Pagets (6)
	Case: Tis (8)
	Case: Invasive (4)
* 2638	Recurrent cancer? (Go To: 2646)
	Permissible Values (value): No (0)
	Yes (1) (Go To: End of Form)
	Unknown (99) (Go To: End of Form)
* 2646	Neoadjuvant therapy(s) administered: (Go To: 1120)
	Permissible Values (value): Surgery (3)
	Hormone therapy (4)
	None (44)
	Other (95)
	Unknown (99)
* 1120	Breast T-Stage, Pathologic (Go To: 1703)
	Permissible Values (value): pTX (1) (Go To: 1706)
	pT0 (2) (Go To: 1706)
	pTis (4) (Go To: 1706)
	pTis (DCIS) (5) (Go To: 1706)
	pTis (LCIS) (6) (Go To: 1706)
	pTis (Paget’s) (7) (Go To: 1706)
	pT1 (8)
	pT1mic (9)
	pT1a (10)
	pT1b (11)
	pT1c (12)
	pT2 (13)
	pT3 (16)
	pT4 (19)
	pT4a (20)
	pT4b (21)
	pT4c (22)
	pT4d (23)
	Unknown (99)
* 1703	Pathologic primary invasive tumor size (cm): (Go To: 1706)
* 1706	Breast N Stage, Pathologic : (Go To: 1707)
	Permissible Values (value): pNX (1)
	pN0 (2)
	pN0(i+) (3)
	pN0(i-) (4)
	pN0(mol-) (5)
	pN0(mol+) (6)
	pN1 (7)
	pN1mi (8)
	pN1a (9)
	pN1b (10)
	pN1c (11)
	pN2 (12)
	pN2a (13)
	pN2b (14)
	pN3 (15)
	pN3a (16)
	pN3b (17)
	pN3c (18)
	Unknown (99)
* 1707	Breast M Stage, Pathologic: (Go To: 1708)
	Permissible Values (value): pMX (1)
	pM0 (2)
	pM1 (3)
	Unknown (99)
* 1708	Stage Grouping, Pathologic (Breast) (Go To: 1638)
	Permissible Values (value): 0 (1)
	I (2)
	IIA (3)
	IIB (4)
	IIIA (6)
	IIIB (7)
	IIIC (8)
	IV (10)
	Not reported (99)
* 1638	Estimated tumor size by imaging (cm) (Go To: 1701)
* 1701	Pathological tissue site: (Go To: 1643)
	Permissible Values (value): Primary (1)
	Regional nodal (2)
	Distant metastasis (3)
	Other, specify: (97) (Go To: 1702)
	Unknown (99)
* 1702	Pathological tissue site (Other, specify): (Go To: 1643)
* 1643	Histological type (breast): (Go To: 1646)
	Permissible Values (value): Adenoid Cystic (1)
	Ductal (4)
	Lobular (5)
	Papillary (6)
	Micropapillary (7)
	Metaplastic (8)
	Metastatic to breast (9)
	Medullary (10)
	Mucinous (colloid) (11)
	Malignant phyllodes tumor (12)
	Tubular (13)
	Other, specify: (97) (Go To: 1644)
	Unknown (99)
* 1644	Histological type, other specify (breast): (Go To: 1646)
* 1646	Nuclear Grade (Go To: 1647)
	Permissible Values (value): 1 pt (1)
	2 pts (2)
	3 pts (3)
	Indeterminate (7)
	Unknown (99)
* 1647	Mitotic Count (Go To: 1705)
	Permissible Values (value): 1 pt (1)
	2 pts (2)
	3 pts (3)
	Indeterminate (7)
	Unknown (99)
* 1705	Histologic grade (Nottingham): (Go To: 1649)
	Permissible Values (value): Grade I (low) (1)
	Grade II (intermediate) (2)
	Grade III (high) (3)
	Indeterminate (7)
	Unknown (99)
* 1649	Dermal lymphatics invasion (Go To: 1650)
	Permissible Values (value): No (0)
	Yes (1)
	Suspicious (3)
	Not specified (99)
* 1650	Lymphovascular invasion (Go To: 1653)
	Permissible Values (value): No (0)
	Yes (1)
	Suspicious (3)
	Not specified (99)
* 1653	Presence of necrosis (Go To: 1655)
	Permissible Values (value): No (0)
	Yes (1)
	Not specified (99)
* 1655	Is DCIS present? (Go To: 1663)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 1656)
	Not specified (99)
* 1656	DCIS histological type: (Go To: 1658)
	Permissible Values (value): Clinging (1)
	Comedo (2)
	Cribriform (3)
	Intra-cystic (encysted papillary) (4)
	Papillary (6)
	Micropapillary (7)
	Solid (8)
	Solid and papillary (9)
	Other, specify: (97) (Go To: 1657)
	Not specified (99)
* 1657	DCIS histological type, other specify: (Go To: 1658)
* 1658	Pathologic primary DCIS tumor size (cm): (Go To: 1659)
* 1659	DCIS nuclear grade: (Go To: 1660)
	Permissible Values (value): Grade I (low) (1)
	Grade II (intermediate) (2)
	Grade III (high) (3)
	Indeterminate (7)
	Unknown (99)
* 1660	Is necrosis present for DCIS? (Go To: 1663)
	Permissible Values (value): No (0)
	Yes (1)
	Not specified (99)
* 1663	Is LCIS present? (Go To: 1671)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 1664)
	Not specified (99)
* 1664	Extent of LCIS (Go To: 1666)
	Permissible Values (value): Focal (1)
	Extensive (3)
	Not specified (99)
* 1666	Is necrosis present for LCIS? (Go To: 1671)
	Permissible Values (value): No (0)
	Yes (1)
	Not specified (99)
* 1671	Estrogen receptor marker test method: (Go To: 1673)
	Permissible Values (value): Immunohistochemistry (IHC) (1)
	Other, specify: (97) (Go To: 1672)
	Unknown (99)
* 1672	Estrogen receptor marker test method, other specify: (Go To: 1673)
* 1673	Percentage of tumor cells with nuclear staining for estrogen: (Go To: 1674)
* 1674	Intensity of estrogen staining: (Go To: 1675)
	Permissible Values (value): Weak (1+) (1)
	Moderate (2+) (2)
	Not reported (3)
	Strong (3+) (4)
	Unknown (99)
* 1675	Final estrogen receptor status diagnosis: (Go To: 1676)
	Permissible Values (value): Positive (1)
	Negative (2)
	Indeterminate (7)
	Unknown (99)
* 1676	Progesterone receptor marker test method: (Go To: 1678)
	Permissible Values (value): Immunohistochemistry (IHC) (1)
	Other, specify: (97) (Go To: 1677)
	Unknown (99)
* 1677	Progesterone receptor marker test method, other specify: (Go To: 1678)
* 1678	Percentage of tumor cells with nuclear staining for progesterone: (Go To: 1679)
* 1679	Intensity of progesterone staining: (Go To: 1680)
	Permissible Values (value): Weak (1+) (1)
	Moderate (2+) (2)
	Not reported (3)
	Strong (3+) (4)
	Unknown (99)
* 1680	Final progesterone receptor status diagnosis: (Go To: 1681)
	Permissible Values (value): Positive (1)
	Negative (2)
	Indeterminate (7)
	Unknown (99)
* 1681	Was HER-2/neu assessed? (Go To: 1682)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 1683)
	Unknown (99)
* 1683	HER-2/neu score (Go To: 1685)
	Permissible Values (value): 0 (1)
	1+ (2)
	2+ (3)
	3+ (4)
	Unknown (99)
* 1685	Final diagnosis with HER2/neu: (Go To: 1682)
	Permissible Values (value): Positive (1)
	Negative (2)
	Equivocal (3)
	Not specified (99)
* 1682	Breast marker test method: (Go To: 1686)
	Permissible Values (value): Immunohistochemistry (IHC) (1)
	Fluorescence in situ hybridization (FISH) (2) (Go To: 1684)
	Other (95)
	Unknown (99)
* 1684	FISH result: (Go To: 1686)
	Permissible Values (value): Not amplified (1)
	Amplified (2)
	Unknown (99)
* 1686	Total number of lymph nodes with metastasis (>0.02 cm) (Go To: 1687)
* 1687	Total number of lymph nodes examined : (Go To: 1688)
* 1688	Size of largest metastasis (cm) (Go To: 1689)
* 1689	Extracapsular/extranodal extension (Go To: 4762)
	Permissible Values (value): No (0)
	Yes (1)
	Not specified (99)
* 4762	Identifier linking to associated image file (Go To: 2596)
* 2596	Date of biopsy (MM/DD/YYYY) (Go To: 3373)
* 3373	Location of breast procedure: (Go To: 3390)
	Permissible Values (value): Left breast (1)
	Right breast (2)
	Bilateral (5)
	Unknown (99)
* 3390	Breast quadrant(s) of procedure: (Go To: 4766)
	Permissible Values (value): Upper inner (1)
	Upper outer (2)
	Lower inner (3)
	Lower outer (4)
	Unknown (99)
* 4766	Clock face value (check all that apply) (Go To: 2597)
	Permissible Values (value): 1:00 (1)
	2:00 (2)
	3:00 (3)
	4:00 (4)
	5:00 (5)
	6:00 (6)
	7:00 (7)
	8:00 (8)
	9:00 (9)
	10:00 (10)
	11:00 (11)
	12:00 (12)
	Central (13)
	Not reported (90)
* 2597	Is this the initial diagnostic biopsy for the current presentation of disease? (Go To: 1636)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 1636	What was the mode of breast cancer detection? (check all that apply) (Go To: 1690)
	Permissible Values (value): Ultrasound (1)
	Mammography (2) (Go To: 1700)
	MRI (4)
	Other, specify: (97) (Go To: 2592)
	Unknown (99)
* 2592	Mode of detection (Other, specify): (Go To: 1690)
* 1700	If a mammogram was the mode of detection, was it incident (first ever screen) or prevalent (prior mammogram)? (Go To: 1690)
	Permissible Values (value): Incident (1)
	Prevalent (2)
	Unknown (99)
* 1690	Benign histologic types: (check all that apply) (Go To: 1669)
	Permissible Values (value): Atypical ductal hyperplasia (ADH) (1)
	Atypical lobular hyperplasia (ALH) (2)
	Cysts (5)
	Fat necrosis (6)
	Lactational change (7)
	Mastitis (8)
	Nipple adenoma (10)
	Papilloma/papillomatosis (12)
	Sclerosing adenosis (13)
	Unspecified non-proliferative findings (15)
	Unspecified proliferative fibrostic changes with atypia (16)
	Unspecified proliferative fibrostic changes without atypia (17)
	Complex sclerosing lesion (20)
	Fibroadenoma (21)
	Radial scar (22)
	Usual ductal hyperplasia (23)
	Apocrine metaplasia (24)
	Not reported (99)
* 1669	Were microcalcifications present? (Go To: 3163)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 1670)
	Not specified (99)
* 1670	In what kind of tissue were microcalcifications present? (Go To: 3163)
	Permissible Values (value): Involving benign tissue (1)
	Involving DCIS (2)
	Involving LCIS (3)
	Involving invasive cancer (4)
	Unknown (99)
3163	Loop-specific comments 2: (Go To: 1097)
* 2602	Is this a routine screening (with no prior knowledge of disease) procedure? (Go To: 2590)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 2590	Was clinical exam performed? (Go To: 1097)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
1097	Comments (do not include any participant identifiers) (Go To: End of Form)