National Longitudinal Cohort of Hematological Diseases (NICHE)
Conditions: Multiple Myeloma, Acute Myeloid Leukemia, Hemophilia, Hemophilia A, Hemophilia B, Myelodysplastic Syndrome, MDS, Lymphoma, Leukemia, Aplastic Anemia, Bleeding Disorder, Bone Marrow Transplantation, Blood Disease Infection, Autoimmune Hemolytic Anemia, AIHA, Essential Thrombocythemia, ET, Large Granular Lymphocyte Leukemia, LGLL, Paroxysmal Nocturnal Hemoglobinuria, PNH
Sponsor: Institute of Hematology & Blood Diseases Hospital, China

 
National Longitudinal Cohort of Hematological Diseases 
- Leukemia 
(NICHE- Leukemia) 
 
 
 
 
 
 
Applicant: Institute of Hematology & Blood Diseases Hospital 
Version: 1.0 
NCT Number: NCT04645199 
Date: 9-Feb-2021 
 
 

 
National Longitudinal Cohort of Hematological Diseases- Leukemia (NICHE- 
Leukemia) 
 
Background 
Hematological diseases are disorders of the blood and hematopoietic organs. The 
current hematological cohorts are mostly based on single-center or multi-center cases, 
or cohorts with limited sample size in China. There is a lack of comprehensive and 
large-scale prospective cohort studies in hematology.  
 
Objectives 
The objectives of this study are to investigate the incidence and risk factors of leukemia 
and to analyze the treatment methods, prognosis and medical expenses of these patients 
in China. 
 
Subjects 
Patients who were diagnosed with leukemia in the investigating hospitals from August 
2, 2021. 
 
Method 
The NICHE-Leukemia will collect basic information, diagnostic and treatment 
information, as well as medical expense information of patients from medical records. 
The study will use questionnaire to measure the exposure of patients, and prospectively 
follow-up to collect the prognosis information. 
 
Statistical Analysis Plan 
Statistical analyses will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC, 
USA) software. For the categorical variables, the results will be presented as counts and 
percentages. The differences between groups were compared with Chi-square test or 
Fisher's exact test. For continuous variables, mean ± SD or median (P25, P75) will be 
presented according to the distributions. The differences between groups were 
compared with ANOVA or Wilcoxon rank-sum test. For time-to-event variables, the 
incidences of events were described using the Kaplan-Meier method and compared 
between groups using the log-rank test. Cox proportional hazard regression modes were 
used for multivariate analyses. A P-value of less than 0.05 was considered to indicate 
statistical significance. 
 

 
 
National Longitudinal Cohort of Hematological Diseases 
- Myelodysplastic Syndrome 
(NICHE- MDS) 
 
 
 
 
 
 
Applicant: Institute of Hematology & Blood Diseases Hospital 
Version: 1.0 
NCT Number: NCT04645199 
Date: 9-Feb-2021 
 
 

 
National Longitudinal Cohort of Hematological Diseases- Myelodysplastic Syndrome 
(NICHE- MDS) 
 
Background 
Hematological diseases are disorders of the blood and hematopoietic organs. The 
current hematological cohorts are mostly based on single-center or multi-center cases, 
or cohorts with limited sample size in China. There is a lack of comprehensive and 
large-scale prospective cohort studies in hematology.  
 
Objectives 
The objectives of this study are to investigate the incidence and risk factors of 
Myelodysplastic Syndrome (MDS) and to analyze the treatment methods, prognosis 
and medical expenses of these patients in China. 
 
Subjects 
Patients who were diagnosed with MDS in the investigating hospitals from August 3, 
2021. 
 
Method 
The NICHE-MDS will collect basic information, diagnostic and treatment information, 
as well as medical expense information of patients from medical records. The study 
will use questionnaire to measure the exposure of patients, and prospectively follow-up 
to collect the prognosis information. 
 
 
Statistical Analysis Plan 
Statistical analyses will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC, 
USA) software. For the categorical variables, the results will be presented as counts and 
percentages. The differences between groups were compared with Chi-square test or 
Fisher's exact test. For continuous variables, mean ± SD or median (P25, P75) will be 
presented according to the distributions. The differences between groups were 
compared with ANOVA or Wilcoxon rank-sum test. For time-to-event variables, the 
incidences of events were described using the Kaplan-Meier method and compared 
between groups using the log-rank test. Cox proportional hazard regression modes were 
used for multivariate analyses. A P-value of less than 0.05 was considered to indicate 
statistical significance. 
 

 
National Longitudinal Cohort of Hematological Diseases 
- Lymphoma 
(NICHE- Lymphoma) 
 
 
 
 
 
 
Applicant: Institute of Hematology & Blood Diseases Hospital 
Version: 1.0 
NCT Number: NCT04645199 
Date: 9-Feb-2021 
 
 

 
National Longitudinal Cohort of Hematological Diseases- Lymphoma (NICHE- 
Lymphoma) 
 
Background 
Hematological diseases are disorders of the blood and hematopoietic organs. The 
current hematological cohorts are mostly based on single-center or multi-center cases, 
or cohorts with limited sample size in China. There is a lack of comprehensive and 
large-scale prospective cohort studies in hematology.  
 
Objectives 
The objectives of this study are to investigate the incidence and risk factors of 
Lymphoma and to analyze the treatment methods, prognosis and medical expenses of 
these patients in China. 
 
Subjects 
Patients who were diagnosed with Lymphoma in the investigating hospitals from 
August 2, 2021. 
 
Method 
The NICHE-Lymphoma will collect basic information, diagnostic and treatment 
information, as well as medical expense information of patients from medical records. 
The study will use questionnaire to measure the exposure of patients, and prospectively 
follow-up to collect the prognosis information. 
 
Statistical Analysis Plan 
Statistical analyses will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC, 
USA) software. For the categorical variables, the results will be presented as counts and 
percentages. The differences between groups were compared with Chi-square test or 
Fisher's exact test. For continuous variables, mean ± SD or median (P25, P75) will be 
presented according to the distributions. The differences between groups were 
compared with ANOVA or Wilcoxon rank-sum test. For time-to-event variables, the 
incidences of events were described using the Kaplan-Meier method and compared 
between groups using the log-rank test. Cox proportional hazard regression modes were 
used for multivariate analyses. A P-value of less than 0.05 was considered to indicate 
statistical significance. 
 
 

 
National Longitudinal Cohort of Hematological Diseases 
- Bleeding Disorders 
(NICHE- BD) 
 
 
 
 
 
 
Applicant: Institute of Hematology & Blood Diseases Hospital 
Version: 1.0 
NCT Number: NCT04645199 
Date: 9-Feb-2021 
 
 

 
National Longitudinal Cohort of Hematological Diseases- Bleeding Disorders 
(NICHE- BD) 
 
Background 
Hematological diseases are disorders of the blood and hematopoietic organs. The 
current hematological cohorts are mostly based on single-center or multi-center cases, 
or cohorts with limited sample size in China. There is a lack of comprehensive and 
large-scale prospective cohort studies in hematology.  
 
Objectives 
The objectives of this study are to investigate the incidence and risk factors of bleeding 
disorders and to analyze the treatment methods, prognosis and medical expenses of 
these patients in China. 
 
Subjects 
Patients who were diagnosed with bleeding disorders in the investigating hospitals from 
August 2, 2021. 
 
Method 
The NICHE-BD will collect basic information, diagnostic and treatment information, 
as well as medical expense information of patients from medical records. The study 
will use questionnaire to measure the exposure of patients, and prospectively follow-up 
to collect the prognosis information. 
 
 
Statistical Analysis Plan 
Statistical analyses will be performed using SAS 9.4 (SAS Institute Inc., Cary, NC, 
USA) software. For the categorical variables, the results will be presented as counts and 
percentages. The differences between groups were compared with Chi-square test or 
Fisher's exact test. For continuous variables, mean ± SD or median (P25, P75) will be 
presented according to the distributions. The differences between groups were 
compared with ANOVA or Wilcoxon rank-sum test. For time-to-event variables, the 
incidences of events were described using the Kaplan-Meier method and compared 
between groups using the log-rank test. Cox proportional hazard regression modes were 
used for multivariate analyses. A P-value of less than 0.05 was considered to indicate 
statistical significance.