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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