Table 3.
Data collection
| Screening | Baseline | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | Annually | |
| Survival status | Continuous registration | ||||||||||
| Toxicity according to CTC (≥grade 3) and BMT-CTN (viral infections) | X | X | X | X | X | X | X | X | X | X | X |
| mRSS | X | X | X | X | X | X | X | X | X | X | X |
| Laboratory | |||||||||||
| ESR, Hb, WBC with differential, platelet count, C3, C4, C1q | X | X | X | X | X | X | X | X | X | ||
| Electrolytes, renal, liver function tests, albumin, troponin, NT-ProBNP | X | X | X | X | X | X | X | X | X | ||
| Autoantibody titres (ANA, ENA, ATA, ARA) | X | ||||||||||
| Urine spot test: creatinin/protein ratio | X | X | X | X | |||||||
| Serology CMV, EBV, HBV, HCV, HIV, HSV, HTLV-1,2, VDRL, VZV | X | X | X | X | |||||||
| Immunophenotyping by FACS of PBMCs: CD3+, CD4+, CD8+, CD4 CD45 RA, CD4+ CD45 RO, CD3−CD56+CD16+, CD19+, CD14+; IgG, IgA, IgM |
X | X | |||||||||
| Women: FSH, anti-Müllerian hormone Men: TSH, testosterone, prolactin |
X | X | |||||||||
| Blood and urine samples for immunological studies and ATG levels | X | X | X | X | X | X | X | X | |||
| Image studies | |||||||||||
| HR-CT | X | X | |||||||||
| Pulmonary function studies | X | X | X | X | X | X | |||||
| 24-hour ECG Holter | X | ||||||||||
| Cardiac echo | X | X | X | X | |||||||
| Cardiac MR | X | X | |||||||||
| Right heart catheterisation | X | ||||||||||
| 18F FDG-PET scan of the thorax | X | X | |||||||||
| Nailfold capillaroscopy | X | X | X | X | X | X | |||||
| Sampling | |||||||||||
| Two biopsies from affected skin | X | X | |||||||||
| Other scores | |||||||||||
| Physician global assessment | X | X | X | X | X | X | |||||
| Modified HAMIS | X | X | X | X | X | ||||||
| PROMS | |||||||||||
| Patient global assessment | X | X | X | X | X | X | |||||
| SHAQ | X | X | X | X | X | X | |||||
| VAS | X | X | X | X | X | X | |||||
| EQ-5D-5L | X | X | X | X | X | X | |||||
| UCLA SCTC GIT 2.0 | X | X | X | X | X | X | |||||
| SFQ-28 (women) or IIEF-15 (men) | X | X | X | X | X | X | |||||
| FACIT | X | X | X | X | X | X | |||||
| Customised iPCQ | X | X | X | X | X | X | |||||
| PASTUL (self-assessment of skin) | X | X | X | X | X | X | X | X | X | X | |
ANA, antinuclear antibody; ARA, anti-RNA polymerase III antibodies; ATA, anti-topoisomerase antibodies; ATG, antithymocyte globulin; BMT-CTN, Bone Marrow Transplant Clinical Trials Network; CMV, cytomegalovirus; CTC, common toxicity criteria; EBV, Epstein-Barr virus; EQ-5D-5L, EuroQol five dimensions five levels; ESR, estimated sedimentation rate; FACIT, Functional Assessment of Chronic Illness Therapy; FDG-PET, fluorodeoxyglucose-positron emission tomography; FSH, follicle stimulating hormone; HAMIS, Hand Mobility in Scleroderma; Hb, haemoglobulin; HBV, hepatitis B virus; HCV, hepatitis C virus; HR-CT, high-resolution CT; HSV, herpes simplex virus; IIEF-15, International Index of Erectile Function; iPCQ, iProductivity Cost Questionnaire; mRSS, modified Rodnan skin score; NT-ProBNP, N-terminal pro-brain natriuretic peptide; PASTUL, Patient self-Assessment of Skin Thickness in Upper Limb; PBMCs, peripheral blood mononuclear cells; PROM, patient-reported outcome measure; SFQ-28, Sexual Functioning Questionnaire; SHAQ, Scleroderma Health Assessment Questionnaire; TSH, thyroid stimulating hormone; UCLA SCTC GIT, University of California, Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument; VAS, visual analogue scale; VDRL, Venereal Disease Research Laboratory; VZV, varicella zoster virus; WBC, white blood count.