Eusoma Certification Process for quality in comprehensive and multidisciplinary breast care

Model dataset for assessing compliance by Breast Units to EUSOMA Certification requirements

• Data should be exported in a CSV (Comma Separated Values) file using ; as separator.

• The first line of the CSV file should contain the list of the exported columns/variables: PERSON_ID;LESION_ID;AGE;BRCA1;BRCA2...

• In order to export missing values in whatever variable, please do not use any character.

• All dates should be exported in the format DD/MM/YYYY

• The CODED variables should be exported using only the given values: no other codes are allowed.

• The yellow background variables have been added to the version 3 of the EUSOMA dataset.

• You may omit whatever column/variable, except for the two identification variables PERSON_ID and LESION_ID.

EUSOMA model dataset (Version 3.1, April 2019)

The bold underlined variables are part of the minimum dataset whose completeness is checked for the certification.

Content Name Type
Personal ID identifying the patient PERSON_ID Text (16) Mandatory variable
Number identifying the lesion in the patient (1,2,3...) LESION_ID Numeric Integer Mandatory variable
Age of the patientAGENumericInteger
BRCA1BRCA1Coded
0
No genetic assessment
1
Negative
2
Positive
9
Unknown
SexSEXCoded
F
Female
M
Male
Eligible for exclusionEXCLUSIONCoded
0
No
1
Previous breast intervention(s) for the same lesion elsewhere
2
Not a primary cancer
BRCA2BRCA2Coded
0
No genetic assessment
1
Negative
2
Positive
9
Unknown
Side location of the lesionB01Coded
R
Right
L
Left
N
Unkwnown
Classification with respect to other lesionsB03Coded
1
Single or main
2
Double contralateral
3
Double ipsilateral
4
Metachronous contralateral
5
Metachronous ipsilateral
9
Unknown
Source of referralD01Coded
1
Referral from screening programme
2
Other
9
Unknown
Result of mammogramD02Coded
0
Not performed
1
R1-Negative
2
R2-Benign lesion
3
R3-Abn. indetermined significance
4
R4-Suspicious of malignancy
5
R5-Malignant features
9
Unknown
Date of mammogramD03DateDD/MM/YYYYRelevant only for mammogram performed
Ultrasound scanD06Coded
0
Not performed
1
U1-Negative
2
U2-Benign lesion
3
U3-Abn. indetermined significance
4
U4-Suspicious of malignancy
5
U5-Malignant features
9
Unknown
Date of ultrasound scanD07DateDD/MM/YYYYRelevant only for ultrasound performed
MRID51Coded
0
Not performed
7
MR0-Incomplete
1
MR1-Negative
2
MR2-Benign
3
MR3-Probably benign
4
MR4-Suspicious
5
MR5-Highly suspicious
6
MR6-Known biopsy proven malignancy
9
Unknown
Date of MRID52DateDD/MM/YYYYRelevant only for MRI performed
Cytological result (FNA)D08Coded
0
Not performed
1
C1-Inadequate
2
C2-Benign epithelial cells
3
C3-Atypia probably benign
4
C4-Suspicious of malignancy
5
C5-Malignant
9
Unknown
Date of sampleD08ADateDD/MM/YYYYRelevant only for FNA performed
Core biopsy (CB) resultD09Coded
0
Not performed
1
B1-Unsatisfactory/Normal
2
B2-Benign
3
B3-Benign uncertain
4
B4-Suspicious of malignancy
5
B5-Malignant
9
Unknown
Type of invasion at CBD10Coded
1
In situ
2
Invasive
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Date of CBD10ADateDD/MM/YYYYRelevant only for core biopsy performed
Technique (CB)D12Coded
1
Tru-cut
2
Vacuum assisted
3
Other
9
Unknown
Relevant only for core biopsy performed
Istotype at CBD41Coded
1
Ductal
2
Lobular
3
Tubular
4
Other
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Grade at CBD42Coded
1
Low
2
Medium
3
High
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Oestrogen receptor status at CBD68Coded
0
Not performed
1
Negative
2
Positive
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Progesterone receptor status at CBD69Coded
0
Not performed
1
Negative
2
Positive
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Proliferation activity (Ki67) at CBD66Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
Ki67 positive cells (%) at CBD67NumericIntegerRelevant only for B4/B5 with neoadjuvant CT
Her2 overexpression (with immunohystochemistry) at CBD74Coded
0
Not performed
1
Negative 0/1+
2
Dubious 2+
3
Positive 3+
9
Unknown
Relevant only for B4/B5 with neoadjuvant CT
FISH hybridization at CBD76Coded
0
Not amplified
1
Amplified
2
Dubious
9
Unknown
Relevant only for Her2 Dubious 2+
Clinical examinationD13ACoded
0
Not performed
1
No physical signs
2
Probably benign
3
Suspicious of malignancy
8
Unknown (palpable)
9
Unknown
Disease extent by imaging or clinical examinationD11Coded
0
Localized
1
Multifocal
2
Multicentric
9
Unknown
Tumour size by imaging or clinical examinationD16NumericInteger
T by imaging or clinical examinationD19Text (3)Relevant only for malignant lesions
N (Regional nodes affected)D20Coded
X
0
1
2
3
4
Relevant only for malignant lesions
M (Distant metastases)D21Coded
X
0
1
Relevant only for malignant lesions
Date of decision to operate or 1st therapy referralD23DateDD/MM/YYYY
Recommendations to patient following assessmentD24Coded
0
None
1
Normal controls
2
Follow-up
3
Exeresis
4
Neoadjuvant therapy
10
Only HT
11
Only CT
5
Only RT
6
Only RT+CT
7
Assessment incomplete
8
Assessment refused
9
Unknown
Relevant only for malignant lesions
Patient operatedN00Coded
0
No
1
Yes
9
Unknown
Reason for non-interventionN00ACoded
0
Not yet operated
1
Refusal
2
Inoperable cancer
9
Unknown
Relevant only for non operated lesions
Date of 1st breast operationE05DateDD/MM/YYYYRelevant only for operated lesions
Type of 1st interventionE08Coded
2
Excisional biopsy/Lumpectomy
3
Wide resection
4
Quadrantectomy
5
Subcutaneous mastectomy
6
Mastectomy
7
Skin sparing mastectomy
8
Other
9
Unknown
Relevant only for operated lesions
Specimen X-ray (1st breast operation)E13Coded
0
No
1
Yes 1 view
2
Yes 2 views
3
Yes
9
Unknown
Relevant only for first intervention performed
Result of RX specimen (1st breast operation)E13BCoded
0
No lesion
1
Lesion present and centred
2
Lesion present but not centred
9
Unknown
Relevant only for specimen X-ray performed
Result of frozen section of the lesionE14Coded
0
Not performed
1
Negative
2
Dubious
3
Positive for CIS
4
Positive for inv. Ca.
5
Performed but result unknown
9
Unknown
Relevant only for first intervention performed
Result of frozen section (specimen margins)E15Coded
0
Not performed
1
T does not reach margin
2
CIS in proximity
3
Inv. ca. in proximity
4
CIS reaches margin
5
Inv. Ca. reaches margins
6
Performed but result unknown
9
Unknown
Relevant only for first intervention performed
Weight (gr.) of the specimen (benign lesion)E16NumericIntegerRelevant only for benign lesions
Second breast operationF01Coded
0
No
1
Yes
9
Unknown
Relevant only for first intervention performed
Date of 2nd breast operationF05DateDD/MM/YYYYRelevant only for second intervention performed
Type of 2nd interventionF08Coded
2
Lumpectomy
3
Wide resection
4
Quadrantectomy
5
Subcutaneous mastectomy
6
Mastectomy
7
Skin sparing mastectomy
8
Other
9
Unknown
Relevant only for second intervention performed
Date of 3rd breast operationF38DateDD/MM/YYYYRelevant only for third intervention performed
Type of 3rd interventionF40Coded
3
Wide resection
4
Quadrantectomy
5
Subcutaneous mastectomy
6
Mastectomy
7
Skin sparing mastectomy
8
Other
9
Unknown
Relevant only for third intervention performed
SLNB procedureP01Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for in situ, micro- and invasive lesions
Date of intervention on sentinel lymph nodeP07DateDD/MM/YYYYRelevant only for lesions treated with sentinel lymphnode
SLNB (Blue Dye)P10Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for lesions treated with sentinel lymphnode
SLNB (Radio guided)P19Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for lesions treated with sentinel lymphnode
Axillary dissectionG01Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for in situ, micro- and invasive lesions
Date of axillary dissectionG07DateDD/MM/YYYYRelevant only for lesions treated with axillary dissection
Type of axillary dissection (level)G09Coded
1
Level I
2
Levels I+II
3
Levels I+II+III
4
Sampling
9
Unknown
Relevant only for lesions treated with axillary dissection
Total or partial excision of pectoral musclesG14Coded
1
Both intact
2
Minor removed
3
Both removed
9
Unknown
Relevant only for lesions treated with axillary dissection
Immediate reconstructionH04Coded
0
Not performed
1
Performed
9
Unknown
Relevant only for lesions with mastectomy
Failed biopsyH07Coded
0
No
1
Yes
9
Unknown
Date of failed biopsyH08DateDD/MM/YYYYRelevant only for failed biopsies
Final pathologyI01Coded
1
Benign
2
In situ
3
Microinvasive
4
Invasive
5
Non epithelial
6
Other
9
Unknown
Relevant only for lesions operated
Other main diagnosis at final pathologyI02Text (13)Relevant only for lesions with "other" diagnosis
DCIS componentI03Coded
0
Absent
1
Present
2
E.I.C.
9
Unknown
Relevant only for invasive lesions
Histological type of benign lesionsI05Coded
0
Normal tissue
1
Fibroadenoma
2
Cysts
3
Atyp.ductal hyperplasia
4
Atyp.lobular hyperplasia
5
Atyp.apochrine metaplasia
6
Fibrocystic mastopatia
7
Ben.phylloid tumor.
8
Schlerosing adenosis
9
Radial scar
10
Papilloma/papillomatosis
88
Other
99
Unknown
Invasive histological type at final pathologyI06Coded
1
Ductal NST
2
Lobular
3
Medullary
4
Mucinous
5
Tubular cribriform
6
Mixed ductal/lobular
7
Mixed ductal NST + other
8
Mixed tubular/lobular
10
Metastatis
11
Other
88
Not assessable
99
Unknown
Relevant only for micro- and invasive lesions
Grade of invasive cancerI08Coded
0
Not performed
1
I
2
II
3
III
9
Unknown
Relevant only for micro- and invasive lesions
Classification used for gradeI09Coded
1
OMS
2
Elston-Ellis
3
Other
9
Unknown
Relevant only for grading available
Presence or absence of vascular invasionI10Coded
0
Not seen
1
Yes
2
Uncertain
8
Not evaluated
9
Unknown
Relevant only for micro- and invasive lesions
In situ histological typeI11Coded
1
Ductal NST
2
Ductal solid
3
Comedo
4
Papillary
5
Micropapillary
6
Cribriform
7
Clinging
10
Lobular
11
Other
88
Not assessable
99
Unknown
Relevant only for final pathology in situ
Grade of in situ lesion or in situ componentI13Coded
0
Not performed
1
Low
2
Intermediate
3
High
9
Unknown
Relevant only for final pathology DCIS or DCIS component
Classification used for gradingI14Coded
1
European Group (nuclear grade)
2
Holland et al.
3
Van Nuys
4
Nottingham
9
Unknown
Relevant only for lesions with grading CIS available
Disease extent by post-operative histologyI16Coded
0
Single
1
Multiple
9
Unknown
Relevant only for operated lesions
Pathological size (mm.)I21NumericIntegerRelevant only for operated malignant lesions
Total size (mm. invasive + in situ)I22NumericIntegerRelevant only for operated in situ lesions or invasive with IS component
Evaluation of margins at final pathology after last operationI23Coded
1
T does not reach margins
2
Inv. ca.in proximity
3
Inv.ca.focally reaches margins
4
Inv.ca.reaches margins
5
DCIS in proximity
6
DCIS focally reaches margins
7
DCIS reaches margins
9
Unknown
Relevant only for operated malignant lesions
Minimum distance of tumour from margins (inv.) in millimetersI24NumericIntegerRelevant only for operated micro- or invasive without mastectomy excluding involved margins
Minimum distance of tumour from margins (DCIS) in millimetersI25ANumericIntegerRelevant only for operated in situ lesions (or with IS component) without mastectomy excluding involved margins
pTI26Coded
X
0
IS
1
1A
1B
1C
1MIC
2
3
4
4A
4B
4C
4D
99
Relevant only for operated malignant lesions
LN statusI27Coded
0
Negative
1
Positive
9
Unknown
Relevant only for malignant lesion except those with both SLN and axillary dissection not performed
SLNB histologic resultI29CCoded
2
Not involved
3
Involved
4
Not found
9
Unknown
Relevant only for lesions treated with SLN
pN (SLNB)I29BCoded
X
0(SL)
0(i-)(SL)
0(i+)(SL)
0(mol-)(SL)
0(mol+)(SL)
1mi
1
1a
1b
1c
999
Relevant only for malignant lesion except those with SLN not performed
pNI28Coded
X
0
0(I-)
0(I+)
0(MOL-)
0(MOL+)
1
1mi
1a
1b
1c
2
2a
2b
3
3a
3b
3c
999
Relevant only for malignant lesion except those with axillary dissection not performed
N. of LN examined by the pathologistI29NumericIntegerRelevant only for malignant lesion except those with both SLN and axillary dissection not performed
N. of axillary LN containing tumourI30NumericIntegerRelevant only for lesion with lymphnodes examined
Oestrogen receptor statusI38Coded
0
Not performed
1
Negative
2
Positive
9
Unknown
Relevant only for malignant lesions
Progesterone receptor statusI39Coded
0
Not performed
1
Negative
2
Positive
9
Unknown
Relevant only for malignant lesions
Evaluation method adopted for hormonal receptor statusI40Coded
1
Immunohistochemical
2
Biochemical
3
Immunological
9
Unknown
Relevant only for lesions ER or PgR available
Proliferation activity (Ki67)I66Coded
0
Not performed
1
Performed
9
Unknown
Ki67 positive cells (%)I67NumericInteger
Her2 overexpression (with immunohystochemistry)I69Coded
0
Not performed
1
Negative 0/1+
2
Dubious 2+
3
Positive 3+
9
Unknown
Relevant only for micro- and invasive lesions
FISH hybridizationI71Coded
0
Not amplified
1
Amplified
2
Dubious
9
Unknown
Relevant only for lesions Her2+ (dubious)
Radiotherapy (RT) performedL01Coded
0
No
1
Yes
2
Patient refusal
9
Unknown
Relevant only for malignant lesions
Date of first RT appointmentL03DateDD/MM/YYYYRelevant only for lesion with RT
Date of first RT fractionL04DateDD/MM/YYYYRelevant only for lesion with RT
Scheduled date of last RT fractionL05DateDD/MM/YYYYRelevant only for lesion with RT
Actual date of last RT fractionL06DateDD/MM/YYYYRelevant only for lesion with RT
Conventional RT fractionL07NumericIntegerRelevant only for lesion with RT
Total administered doseL09NumericIntegerRelevant only for lesion with RT
Boost dose administeredL10NumericIntegerRelevant only for lesion with RT
Radiotherapy on breastL11Coded
0
No
1
Cobalt60
2
x-MV
3
Other
8
Yes unknown method
9
Unknown
Relevant only for lesion with RT
Radiotherapy boostL13Coded
0
No
1
Electrons
2
x-MV
3
Interstitial brachytherapy
4
Other
8
Yes unknown method
9
Unknown
Relevant only for lesion with RT
Radiotherapy on AxillaL21Coded
0
No
1
Apex
2
In toto
9
Unknown
Relevant only for lesion with RT
Radiotherapy on chest wallL24BCoded
0
No
1
Yes
9
Unknown
Relevant only for lesion with RT
Radiotherapy on supraclavicular areaL33Coded
0
No
1
Yes
9
Unknown
Relevant only for lesion with RT
Radiotherapy on internal mammary chainL42Coded
0
No
1
Yes
9
Unknown
Relevant only for lesion with RT
Interruption to radiotherapy for technical reasonsL24Coded
0
No
1
Yes
9
Unknown
Relevant only for lesion with RT
Endocrine therapyM01Coded
0
No
1
Yes
2
Patient refusal
9
Unknown
Relevant only for malignant lesions
Ovarian ablationM02Coded
0
No
1
Surgery
2
Radioterapy
3
GnRH analogs
4
Other
9
Unknown
Relevant only for malignant lesions
Hormone therapyM04Coded
0
No
1
Yes
9
Unknown
Relevant only for malignant lesions
Date first hormone therapy cycleM05DateDD/MM/YYYY
Treatment in association with chemotherapyM11Coded
0
No
1
Yes
9
Unknown
Relevant only for malignant lesions
Type of association with chemotherapyM12Coded
1
Synchronous
2
Sequential
9
Unknown
Relevant only for malignant lesions
Neoadjuvant chemotherapyM13Coded
0
No
1
Yes
2
Patient refusal
9
Unknown
Relevant only for malignant lesions
Date of first neoadjuvant chemotherapy cycleM14DateDD/MM/YYYYRelevant only for lesion with neoadjuvant CT
Date of last neoadjuvant chemotherapy cycleM15DateDD/MM/YYYYRelevant only for lesion with neoadjuvant CT
Combination of drugsM15ACoded
1
AC
2
CMF 1-8
3
ePI+CMF 1-8
4
FAC
5
FeC
6
ePI 120
7
CeF 1-8
8
eC
9
ADM-TAX
10
ePI-TAX
11
AT
12
Other
99
Unknown
Relevant only for lesion with CT
Withdrawal due to toxicityM28Coded
0
No
1
Yes
9
Unknown
Relevant only for lesion with CT
Adjuvant chemotherapyM18Coded
0
No
1
Yes
2
Patient refusal
9
Unknown
Relevant only for malignant lesions
Date of first adjuvant chemotherapy cycleM19DateDD/MM/YYYYRelevant only for lesion with adjuvant CT
Date of last adjuvant chemotherapy cycleM20DateDD/MM/YYYYRelevant only for lesion with adjuvant CT
Adjuvant therapy with biological drugsM43Coded
0
Not performed
1
Performed with Trastuzumab
2
Performed with other drug
3
Performed (drug unknown)
4
Patient refusal
9
Unknown
Relevant only for malignant lesions
Date of first administration of biological drugs for adjuvant therapyM46DateDD/MM/YYYY
Local recurrenceFU01Coded
0
No
1
Yes
9
Unknown
Relevant only for malignant lesions
Date of follow-up (or date of local recurrence)FU02DateDD/MM/YYYYRelevant only for malignant lesions
Regional LN recurrenceFU03Coded
0
No
1
Yes
9
Unknown
Relevant only for malignant lesions
Date of follow-up (or date of 1st regional recurrence)FU04DateDD/MM/YYYYRelevant only for malignant lesions
Type of 1st regional recurrenceFU05Coded
1
Ipsilateral axillary
2
Internal mammary
3
Ipsilateral neck
4
Contralateral LN in the axilla
5
Contralateral LN in the neck
Relevant only for lesions with regional recurrence
Distant metastasesFU06Coded
0
No
1
Yes
9
Unknown
Relevant only for malignant lesions
Date of follow-up (or date of 1st distant metastases)FU07DateDD/MM/YYYYRelevant only for malignant lesions
Site of distant metastasesFU08Coded
1
Other LN
2
Bone
3
Liver
4
Pleura
5
Lung
6
Brain
7
Spinal cord and meninges
8
Other
9
Multiple sites
10
Unknown
Relevant only for lesions with distance metastasis
New primary breast cancerFU09Coded
0
No
1
Yes contralateral
2
Yes same breast
9
Unknown
Date of follow-up (or date of new primary breast cancer)FU10DateDD/MM/YYYY
Patient status at follow-upFU11Coded
1
Alive NED
2
Alive with progression of disease
3
Alive (disease status unknown)
4
Died
9
Unknown
Date of follow-up (if died date of death)FU12DateDD/MM/YYYY
Cause of deathFU13Coded
1
With/from breast cancer
2
No known breast cancer present
9
Unknown
Relevant only for dead patients