EBCTCG Fifth Cycle Data Format

One record of confidential data for each woman ever randomised (including any later categorised as ineligible, withdrawn, unevaluable, lost or "protocol deviant"). If any item is not conveniently available, please leave blank.

Please note that this format is provided as a suggestion only. None of the details shown below are mandatory because all records will be converted into a standard internal representation in our database.

cols
BASELINE VARIABLES

1-12 Patient identifier(up to 12 characters)

14-21 Date of randomisation(specify your format for dates)

23 Allocated treatment(specify your codes)

25-26 Age at randomisation (years)

28 Menopausal status at randomisation (1=pre-menopausal, 2=peri-menopausal, 3=post-menopausal)

30 Original surgery(Use and specify your own codes; or use 1=radical mastectomy, 2=total mastectomy, 3=simple mastectomy, 4=partial mastectomy with axillary clearance, 5=partial mastectomy without axillary clearance, 6=lumpectomy with axillary clearance, 7=lumpectomy without axillary clearance)

32 Axillary status at randomisation (Use and specify your own codes ideally providing the number of positive nodes and the number of nodes removed; or use 1=N0 clearance, 2=N1-3 clearance, 3=N4+ clearance, 4=N- sample, 5=N+ sample, 6=N- clinical, 7=N+ clinical)

34 Sentinel node biopsy at randomisation (Use and specify your own codes; or use 1=not done, 2=done and negative, 3=done and positive)

36 Oestrogen receptor (ER) coding (Use the following codes to indicate the units used for the ER measurement: F=fmoles/mg cytosol protein, P=percent cells staining, C=other codes used for ER protein result [please specify codes]). Leave blank if there is no ER value for this woman.

38-41 ER status of primary tumour at the time of original surgery (supply quantitative data if available)

43 Progesterone receptor (PR) coding (Use the following codes to indicate the units used for the PR measurement: F=fmoles/mg cytosol protein, P=percent cells staining, C=other codes used for PR protein result [please specify codes]). Leave blank if there is no PR value for this woman.

45-48 PR status of primary tumour at the time of original surgery (supply quantitative data if available)

50 Laterality of primary tumour(s) at the time of randomisation (0=not available, 1=left, 2=right, 3=bilateral)

52-54 Largest recorded diameter of primary tumour at the time of original surgery (Use millimetres [so, for example, 2cm would be 20] or use and specify your own codes)

56 Histological grade of primary tumour (Use and specify your own codes; or use 1=well differentiated, 2=moderately differentiated, 3=poorly differentiated)

HER2 at the time of randomisation

58 Type of IHC test (HER2 immunohistochemistry, use and specify your own codes; or use 1=not done, 2=done but unspecified, 3=DAKO, 4=TAB 250 5=C11)

60-62 IHC measurement (Use and specify your own codes; or use 0, 1+, 2+, 3+, W/M=weak/moderate, M/S=moderate/strong, or 'xx%')

64 FISH (HER2 filter in-situ hybridisation: use and specify your own codes; or use 1=not done, 2=done)

66-68 FISH measurement (Use and specify your own codes; or provide the actual ratio)

cols
FOLLOW-UP VARIABLES

70 Contralateral breast cancer (1=no, 2=yes; 3=carcinoma in situ, N-; 4=carcinoma in situ, N+; 5=carcinoma in situ, N?; 6=invasive)

72-79 Date of first contralateral breast cancer (specify your format for dates)

81 Site of second malignancy (Use and specify your own codes)
(If you use the WHO's International Classification of Disease [ICD] codes, specify which ICD revision [e.g. 9 or 10] is used)

83-90 Date of diagnosis of second malignancy (specify your format for dates)

92 Any distant recurrence or recurrence of unknown site? (1=no, 2=distant, 3=unknown site, 4=uncertain, 5=CIS, unknown)

94-101 Date of this recurrence (specify your format for dates)

103 Any isolated local recurrence? (Try to distinguish ipsilateral breast or axillary recurrences from other local recurrences. Use and specify your own codes; or use 1=no local recurrence, 2=any local recurrence, 3=ipsilateral breast recurrence, 4=ispilateral axillary recurrence, 5=other locoregional site; 6=recurrent carcinoma in situ, N-; 7=recurrent carcinoma in situ, N+; 8=recurrent carcinoma in situ, N?; 9=invasive)

105-112 Date of local recurrence (specify your format for dates)

114 Status (1=alive, 2=died)

116-123 Date last seen or died (specify your format for dates)

125 Cause of death(Use and specify your own codes)
(If you use the WHO's International Classification of Disease [ICD] codes, specify which ICD revision [e.g. 9 or 10] is used)

Additional information(If you are able to supply data on multiple second malignancies or wish to provide more than one cause of death please add these data to the end of the record for the relevant patient, with an explanation and we will process it accordingly)

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[End of document of 29 April 2005, updated to 2 April 2008]

cols	BASELINE VARIABLES
1-12	Patient identifier(up to 12 characters)
14-21	Date of randomisation(specify your format for dates)
23	Allocated treatment(specify your codes)
25-26	Age at randomisation (years)
28	Menopausal status at randomisation (1=pre-menopausal, 2=peri-menopausal, 3=post-menopausal)
30	Original surgery(Use and specify your own codes; or use 1=radical mastectomy, 2=total mastectomy, 3=simple mastectomy, 4=partial mastectomy with axillary clearance, 5=partial mastectomy without axillary clearance, 6=lumpectomy with axillary clearance, 7=lumpectomy without axillary clearance)
32	Axillary status at randomisation (Use and specify your own codes ideally providing the number of positive nodes and the number of nodes removed; or use 1=N0 clearance, 2=N1-3 clearance, 3=N4+ clearance, 4=N- sample, 5=N+ sample, 6=N- clinical, 7=N+ clinical)
34	Sentinel node biopsy at randomisation (Use and specify your own codes; or use 1=not done, 2=done and negative, 3=done and positive)
36	Oestrogen receptor (ER) coding (Use the following codes to indicate the units used for the ER measurement: F=fmoles/mg cytosol protein, P=percent cells staining, C=other codes used for ER protein result [please specify codes]). Leave blank if there is no ER value for this woman.
38-41	ER status of primary tumour at the time of original surgery (supply quantitative data if available)
43	Progesterone receptor (PR) coding (Use the following codes to indicate the units used for the PR measurement: F=fmoles/mg cytosol protein, P=percent cells staining, C=other codes used for PR protein result [please specify codes]). Leave blank if there is no PR value for this woman.
45-48	PR status of primary tumour at the time of original surgery (supply quantitative data if available)
50	Laterality of primary tumour(s) at the time of randomisation (0=not available, 1=left, 2=right, 3=bilateral)
52-54	Largest recorded diameter of primary tumour at the time of original surgery (Use millimetres [so, for example, 2cm would be 20] or use and specify your own codes)
56	Histological grade of primary tumour (Use and specify your own codes; or use 1=well differentiated, 2=moderately differentiated, 3=poorly differentiated)
	HER2 at the time of randomisation
58	Type of IHC test (HER2 immunohistochemistry, use and specify your own codes; or use 1=not done, 2=done but unspecified, 3=DAKO, 4=TAB 250 5=C11)
60-62	IHC measurement (Use and specify your own codes; or use 0, 1+, 2+, 3+, W/M=weak/moderate, M/S=moderate/strong, or 'xx%')
64	FISH (HER2 filter in-situ hybridisation: use and specify your own codes; or use 1=not done, 2=done)
66-68	FISH measurement (Use and specify your own codes; or provide the actual ratio)

cols	FOLLOW-UP VARIABLES
70	Contralateral breast cancer (1=no, 2=yes; 3=carcinoma in situ, N-; 4=carcinoma in situ, N+; 5=carcinoma in situ, N?; 6=invasive)
72-79	Date of first contralateral breast cancer (specify your format for dates)
81	Site of second malignancy (Use and specify your own codes) (If you use the WHO's International Classification of Disease [ICD] codes, specify which ICD revision [e.g. 9 or 10] is used)
83-90	Date of diagnosis of second malignancy (specify your format for dates)
92	Any distant recurrence or recurrence of unknown site? (1=no, 2=distant, 3=unknown site, 4=uncertain, 5=CIS, unknown)
94-101	Date of this recurrence (specify your format for dates)
103	Any isolated local recurrence? (Try to distinguish ipsilateral breast or axillary recurrences from other local recurrences. Use and specify your own codes; or use 1=no local recurrence, 2=any local recurrence, 3=ipsilateral breast recurrence, 4=ispilateral axillary recurrence, 5=other locoregional site; 6=recurrent carcinoma in situ, N-; 7=recurrent carcinoma in situ, N+; 8=recurrent carcinoma in situ, N?; 9=invasive)
105-112	Date of local recurrence (specify your format for dates)
114	Status (1=alive, 2=died)
116-123	Date last seen or died (specify your format for dates)
125	Cause of death(Use and specify your own codes) (If you use the WHO's International Classification of Disease [ICD] codes, specify which ICD revision [e.g. 9 or 10] is used)
	Additional information(If you are able to supply data on multiple second malignancies or wish to provide more than one cause of death please add these data to the end of the record for the relevant patient, with an explanation and we will process it accordingly)