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Table 2 Data collected in the electronic case record form

From: OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized open label trial

Panel in eCRF Data recorded
Informed consent Date
I/E criteria Yes; not
Demographic data Age at inclusion; Menstrual State
Comorbidities If yes: specify
Cancer Histology and Receptors, SLN OSNA Tumour grade; Tumour size (maximum diameter); P53 (%); Ki67 (%); Lymphovascular infiltration; Ductal Ca in situ; % Estrogenic receptors; % Progesterone receptors; HER2 receptor status; OSNA TTL of SLN
Previous medication (Adjuvant therapy) Drug; Start date; Stop date
Type of surgery Tumour surgery; date; Margins
Randomization Treatment randomly allocated; Randomization date
Radiotherapy intervention Patient completed the allocated treatment (If no: main reason); Start date; End date; Treatment gaps (If yes, reason); Dose per volume (Mean; Median; D95; D5; Volume) in the breast, tumour bed, supraclavicular and axillary levels I-III, and Internal mammary chain
Co-medication Drug; Start date; Stop date
Survival and disease recurrence Date of follow-up visit (If not performed, reason); Local recurrence; Regional recurrence (If yes: nodal level); Distant recurrence (If yes: organ); Vital status (if dead: date and cause)
Image evaluation of local recurrence Technique; Local recurrence (if yes: Maximum diameter)
Physical examinationa Palpable breast tumour (if yes: size, skin infiltration, inflammatory carcinoma, satellite lesions); Palpable axillary nodes (if yes: size); Palpable supraclavicular nodes (if yes: size); Node staging
Acute and chronic toxicity CTCAE term; Grade; Start date; Stop date; Status (recovered w/o sequels; death)
  1. eCRF electronic case record form, OSNA One-Step Nucleic Acid Amplification, TTL total tumour load, SLN sentinel lymph node, CTCAE Common Terminology Criteria for Adverse Events
  2. aPhysical examination is conducted at follow-up visits. It is also addressed at baseline and radiotherapy sessions to confirm the compliance of eligible criteria. If suspicious LNs are detected, the patient will discontinue the study