Family History Screening - Study guidelines: data items

Data items

1. Baseline data not pertaining to family history recorded at recruitment
Name
Address 1
Address 2
Address 3
Address 4
Postcode
NHS number
Hospital number
Study number (study number as used by centre)
Date of birth
Date of recruitment (date consent from signed)
BRCA1 mutation identified in family	Not tested	Positive	Negative	Unknown
BRCA2 mutation identified in family	Not tested	Positive	Negative	Unknown
Personal search (if yes to either of above, has subject been tested for relevant mutation?)	Yes	No		Unknown
Personal BRCA status (if yes to above, was subject positive for relevant mutation?)	Yes	No		Unknown
Menopausal status	Pre (regular periods)		Peri (7-12 months since last period)
	Post (>12 months since last period)		Unknown
Age at menopause (years) (0 if pre- or perimenopausal)
Age at hysterectomy/oopherectomy (years)
HRT use	Never		Previously
	Currently		Unknown
Parity (number of pregnancies to at least 30 weeks
Age at first pregnancy (age at first pregnancy of at least 30 weeks duration)
Age at menarche
Previous screening mammography	Yes	No		N/K
Time since last mammogram (months)
Previous breast biopsy?	No		ADH
	LCIS		Benign NOS
Previous breast surgery?	Yes	No		N/K
How many sisters has the participant's mother?
How many sisters has the participant's father?
Has the family history data been verified from medical records?	Yes	No		N/K

1a. Family history of breast and ovarian cancer taken at baseline- list only relatives with a diagnosis
Relative (first or second degree only)	Maternal/ paternal	Breast cancer (Y/N)	Bilateral (Y/N)	If Y, age first diagnosed	Ovarian cancer (Y/N)	Age first diagnosed

2. Screening and assessment data recorded for each screening episode
Date of mammogram
Screening round	1	2	3	4	5	6
Suspicion left breast (five point score)
Suspicion right breast (five point score)
Mammographic pattern (fatty/mixed/dense)
Recall for assessment (yes/no)
Percutaneous biopsy (yes/no)
Physical examination not done (1) done after mammography result (2) done before mammography result (3) mammography and physical examination results each assessed with knowledge of the other (4)
Ultrasound scan performed not done (1) done after mammography result (2) done before mammography result (3) mammography and USS results each assessed with knowledge of the other (4)
Palpable lump (yes/no)
Other tests 1
Other test 1 result
Other tests 2
Other test 2 result
Surgery/Open biopsy (yes/no)
Final diagnosis (breast cancer, BBD, normal - if cancer form below required)

3. Cancer data - all cancers, whether detected by screening or clinically
Name
NHS number
Screening centre
Study number
Date of diagnosis (date of surgery or date of most definitive test otherwise)
Mode of detection (prevalence screen, incidence screen, interval cancer, clinically diagnosed after non-attendance at last scheduled screen)
Date of mammogram (prompting diagnosis if screen-detected)
Date of last scheduled mammogram (if clinically detected)
Date of last actual mammogram (if clinically detected)
Tumour palpable (on physical examination)
Symptoms (yes/no)
Invasive or insitu
Neoadjuvant chemotherapy Preoperative chemotherapy (yes/no)
Tumour size Pathological size of invasive component (mm)
Lymph nodes examined Number of lymph nodes examined pathologically
Lymph nodes positive Number of pathologically examined nodes with tumour
Axillary surgery (None, sentinel only, sampling, clearance - either immediately or after positive sentinel finding)
Histological grade (1, 2 or 3)
Histological type (DCIS, invasive ductal, lobular, medullary, tubular, mucinous)
Ultrasound size (ultrasonically assessed size if pathology not available - mm)
Mammographic size (if pathology and ultrasound size both unavailable - mm)
Surgery (none, local excision, mastectomy)
Radiotherapy (yes/no)
Hormone therapy (yes/no)
Chemotherapy (yes/no)
Oestrogen receptor status (positive/negative)
Progesterone receptor status (positive/negative)