Table 1.
Main variables
| Variable name | Baseline (B) Follow-up (F) | IWCLL (I) CLL-IPI (C) |
|---|---|---|
| Demographics | ||
| ID | B | |
| Sex | B | |
| Date of birth | B | |
| Age | B | C |
| Family history of CLL | B | |
| Date of diagnostic test | B | |
| Diagnostics and results | ||
| Bone marrow biopsy | B | |
| Absolute lymphocyte count | B | I |
| Flow cytometry | B | I |
| FISH (del 11q, trisomy 12, del 13q14, del 17p) | B | I, C |
| IGHV mutational status | B | I, C |
| Imaging | B | |
| Symptoms and clinical observations | ||
| Weight loss (>10%/6 months) | B | |
| Fever of unknown origin (>2 weeks) | B | |
| Fatigue | B | |
| Night sweat | B | |
| Performance status WHO | B | |
| Binet/Rai | B | I, C |
| Prognostic tests and results | ||
| IGHV mutational status (≥98%) | B | |
| ZAP 70 | B | |
| CD38 positive | B | |
| Beta 2 microglobulin >340 nmol/>4 mg | B | C |
| Lymphocyte doubling time <12 months | B | |
| Anemia (Hb <6.2 mmol/L)/thrombocytopenia (<100 mia/L) | B | |
| Massive-progressive lymphadenopathy/splenomegaly | B | |
| Increasing lymphocytosis (>50%/2 months) | B | |
| Rapid lymphocyte doubling time (<6 months) | B | |
| Follow-up/treatment | ||
| Chemotherapy regimen | F | |
| Immune therapy | F | |
| Date of treatment start | F | |
| Date treatment end | F | |
| Response | F | |
| Date of transplantation (if applicable) | F | |
| MRD analysis performed | F | |
| Date of progression/relapse | F | |
| New FISH result (if applicable) | F | |
| End of follow-up | ||
| Date of death (if applicable) | F | |
| Cause of death | F |
Notes: Main variables categorized as: demographics, diagnostics and results, symptoms and clinical observations, prognostic tests and results, follow-up/treatment, and end of follow-up collected in The Danish National CLL Registry. Baseline (B) data are collected at the time of diagnosis and follow-up (F) data are collected continuously at the time of significant events, including progression, treatment, transplantation, and death. Data of variables included in the IWCLL (I) and the CLL-IPI (C) index are collected.
Abbreviations: ID, identification; CLL, chronic lymphocytic leukemia; IWCLL, International Prognostic Index for Patients with CLL; CLL-IPI, Chronic Lymphocytic Leukemia International Prognostic Index; FISH, fluorescence in situ hybridization; IGHV, immunoglobulin heavy chain variable; WHO, World Health Organization; MRD, minimal residual disease.