BC 1985 - breast cancer - data structure and protocols

Contents List

BC 1985 - breast cancer

BC 1985 data preparation: brief written protocol
Specification of BC 1985 'blue form' format
BC 1985 data form rubric

BC data preparation: brief written protocol

Strict confidentiality of trial results is observed. Information is held in the Clinical Trial Service Unit computers in a form which can be accessed only by known individuals.

All patient records are converted into 'blue form' (1985) format (described below) if not already supplied in it. Results received as tables are converted into sets of synthetic records.

Specification of BC 'blue form' format (1985 overview)

Item

Description

FORTRAN

Columns

Details

Study number

1 - 6

Patient number

8 - 13

Treatment group

Date randomised

17 - 22

DDMMYY

Randomisation age

24 - 25

years

State when last traced

Value	Description
1	Dead
2	Alive
3	Lost - NEW
4	Utterly lost - NEW
5	Alive?, ineligible for protocol - NEW
6	Dead, ineligible for protocol - NEW
7	Alive?, ineligible for review - NEW
8	Dead, ineligible for review - NEW

Date died or last traced

29 - 34

DDMMYYYY

Axillary status on entry

35 - 36

Value	Description
1	N0 (clearance)
2	N1-3 (clearance)
3	N4+ (clearance)
4	N- (sample only)
5	N+ (sample only)
6	N- (clinical)
7	N+ (clinical)
8	N- (method unknown) - NEW
9	N+ (method unknown) - NEW
10	N+ (clearance) - NEW
11	N > 1 (clearance) - NEW
12	N1-3 (method unknown) - NEW
13	N4+ (method unknown) - NEW

Menopausal status on entry

Value	Description
1	Pre-menopausal
2	Peri-menopausal
3	Post-menopausal
4	"Post-meno. surg." - NEW

Ovary ablation

Value	Description
1	Bilateral at or near entry
2	Other

Surgery: first mastectomy

41 - 42

Value	Description
1	Radical
2	Total
3	Simple
4	Partial
5	None
10	Radiotherapy + unknown - NEW
11	Radical + radiotherapy - NEW
12	Total + radiotherapy - NEW
13	Simple + Radiotherapy - NEW
14	Partial + radiotherapy - NEW
15	Radiotherapy - NEW

Oestrogen receptor status

43 - 44

Value	Description
1	Negative
2	Marginal
3	Positive
4	< 10 fmol/mg protein
5	10 - 19 fmol/mg protein
6	20 - 29 fmol/mg protein
7	30 - 49 fmol/mg protein
8	50 - 99 fmol/mg protein
9	100+ fmol/mg protein
10	10 - 29 fmol/mg protein - NEW
11	30 - 100 fmol/mg protein - NEW
12	10 - 99 fmol/mg protein - NEW

Compliance before relapse

Value	Description
1	Poor
2	Medium
3	Good

Treatment on relapse

Value	Description
1	Hormonal
2	Vigorous cytotoxic
3	Hormonal and vigorous cytotoxic
4	Surgery only - NEW
5	Deep X-ray therapy - NEW
6	Deep X-ray and hormonal - NEW
7	Deep X-ray and hormonal - NEW
8	Deep X-ray and cytotoxic - NEW
9	Deep X-ray, cytotoxic and hormonal - NEW

Cause of death

49 - 50

Value	Description
1	Acute treatment toxicity
2	(Other) infective
3	Acute leukaemia
4	Other second neoplasm
5	Heart
6	Thrombotic or embolic
7	Other vascular
8	Trauma
9	Not 1 - 8 and not breast cancer
10	Not breast cancer - NEW
11	Breast cancer or its metastases - NEW

Primary in opposite breast/other site

Value	Description
1	No
2	Apparent at entry
3	Arose later
4	Yes (unspecified time) - NEW
5	Other second primary - NEW
6	Leukaemia - NEW

Recurrence

Value	Description
1	Not recorded
2	Yes

Date of first recurrence

56 - 61

DDMMYY

Distant recurrence

Value	Description
1	Not recorded
2	Yes

Date of first recurrence

65 - 70

DDMMYY

Name and comments

72 - end

Missing or unknown items are left blank or set to zero.

BC 1985 data form rubric

[There will be a link to a picture of the 1985 BC data form here - in preparation]

GUARANTEE OF CONFIDENTIALITY OF DATA

ANY DATA PROVIDED OVERLEAF TO THE BCTCS/NCI/UICC/WHO SECRETARIAT WILL BE HELD SECURELY AND IN STRICT CONFIDENCE AND WILL REMAIN THE PROPERTY OF THE TRIALISTS SUPPLYING IT UNTIL THEY CHOOSE TO PUBLISH IT.

NOTES ON FORMAT OF DATA REQUESTED OVERLEAF

Please accompany these forms by an explanatory letter about any special coding conventions (e.g. on menopausal status, ER or compliance) you have used, plus notes on any special features of the study(s) you wish to draw particular attention to.
Dates that are not (or not yet) known exactly

either leave DAY blank, and give (approximate or provisional) month and year,
or leave DAY AND MONTH blank, and just give approximate year.
Items marked with an asterisk are to be left blank if not applicable, or if data are not yet conveniently available.

ESSENTIAL MINIMUM DATA

Patient number

Any convenient convention you wish, in case any correspondence becomes necessary. (If reporting several trials, please try to use a numbering system that implicitly specifies both the trial and the patient.)

Trt. gp.

Treatment group number: 1 or 2 only, for 2-group trials, or a wider range for trials with more arms, as defined by you at the top of the form. N.B.: even if, in reality, some quite different (or even opposite!) treatment was inadvertently given, what is wanted is the originally-allocated treatment. (For patients erroneously entered more than once, give only the first allocation.)

Date randomised & Entry age

Please describe ALL patients EVER randomised, including even lost or withdrawn patients, and ignore all non-randomised patients.

Dead/other

1 = known to be dead, 2 = alive or lost, but alive when last traced.

Date died/last traced

Date of death, or date last known to be alive, as accurately as possible. (See above note on approximate dates).

Axilla (status on entry)

0 or blank = not (yet) conveniently available; 1, 2, 3 = axillary clearance (1 = N0, 2 = N1-3, 3 = N4+); 4, 5 = axillary sample only (4 = N-, 5 = N+); 6, 7 = no sample (6 = clinically N-, 7 = clinically N+).

Menop. (status on entry)

1 = pre-, 2 = peri-, 3 = post-menopausal. Use your own definitions of menopausal status at entry.

Ovary ablat.

1 = Bilateral ovarian ablation (surgical or otherwise) before, at, or shortly after, entry; 2 = other.

OPTIONAL EXTRA DATA

Surgery

Type of surgery first attempted: 1 = radical, 2 = total, 3 = simple, 4 = partial, 5 = none.

Est. Rec.

Oestrogen receptor status. If exact value is not available use 1 = negative, 2 = marginal, 3 = positive, otherwise use 4, 5, 6, 7, 8, 9 for < 10, 10-19, 20-29, 30-49, 50-99 and 100+ fmol/mg protein respectively.

Comply?

Compliance before any relapse: 1 = poor, 2 = mid, 3 = good compliance, at least until relapse. Use your own definitions: "mid" should involve some appreciable compliance, but some appreciable non-compliance.

Tt. on relapse

Treatment after relapse: 1 = hormonal treatment after relapse, 2 = cytotoxic treatment attempted vigorously after relapse, 3 = both hormonal and vigorous cytotoxic treatment attempted.

Other death

Underlying cause of death, if before first relapse the patient died of another cause while no overt breast cancer was apparent: 0 or blank = not applicable, 1 = acute treatment toxicity, 2 = (other) infective, 3 = acute leukaemia, 4 = other 2nd neoplasm, 5 = heart, 6 = thrombotic or embolic, 7 = other vascular, 8 = suicide, 9 = all other causes (except, of course, breast cancer).

2nd 1ry (i.e. 2nd primary in opposite breast)

1 = no, 2 = already apparent at around time of entry, 3 = arose later.

Recur?

1 = no recurrence yet recorded, 2 = some recurrence (distant or local or ipsilateral 2nd 1ry).

Approx. date of 1st recur?

Give the best estimate you can: see above note on approximate dates.

Dist. recur.

Any distant recurrence? 1 = no, 2 = yes: ignore local disease and regional nodes.

Approx. date dist. recur.

Give the best estimate you can: see note on approximate dates.

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[End of document, updated to 3 June 2000]