Acute Graft-versus-host Disease
Conditions
Keywords
HMGB1 Protein, Graft versus Host Disease, Immunosuppressive Agents, oral mucositis
Brief summary
Acute Graft-versus-host disease(aGVDH) after allogeneic hematopoietic stem cell transplantation is one of the meaningful issues in aspect of patient's recovery and survival. in recent years, the understanding of the pathology of GVHD is much important to prevent or treat aGVHD. additionally, (oral) mucositis is one of the problems in patients with high dose chemotherapy, and mucositis by high-dose chemotherapy is related to HMGB-1 as proinflamtory cytokines. HMGB1 is a nuclear protein acts as a transcription factor, but, if it was released to the outside of cells by damaged cell or necrotic tissues, it works as cytokines for promoter of inflammation and cancers. at this point, there are no reported articles about correlation of HMGB1 and aGVHD in human. recently, we have seen excessive secretion of serum HMGB1 in mouse model, then base on this results, we will check correlation of HMGB1 and aGVHD/ oral mucositis in human.
Detailed description
1. materials 1) inclusion criteria 1. over 18-year-old 2. patients with myeloablative conditioning regimen 3. autologous transplant 4. patients with confirmation of acute GVHD as over grade II 5. patients with salvage chemotherapy 2\) exclusion criteria <!-- --> 1. old age ( over 60-year-old) 2. patients with reduced intensity stem cell transplantation 2. method 1) check the serum level of HMGB1, TNF-a, IL-1b, IL-6, Th1, Th2, Th17, FoxP3 on 7-day before transplant day(D-7), transplant day(D0), 7-day after transplant(D+7), D+14, D+21. 2) check the immunohistochemistry level of tissue in diagnosed aGVHD ( performed sigmoidoscopy and random biopsy of gut is routine process in our center) 3) check the oral mucositis grades (using WHO grading system, NCI -CTC ver.3 scoring system) 3. analysis 1) student t-test , chi-square test 2) survival analysis
Interventions
DRUGsalvage chemotherapy, total body irradiation
there are no direct interventions to our patients.
Sponsors
Seoul St. Mary's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria: 1. over 18-year-old 2. patients with myeloablative conditioning regimen 3. autologous transplant 4. patients with confirmation of acute GVHD as over grade II 5. patients with salvage chemotherapy 2.
Exclusion criteria
1. very old age ( over 75-year-old) 2. patients with reduced intensity stem cell transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison of serum HMGB1 level before and after diagnosed acute GVHD | 6 months | day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum level of immunosuppressive drugs in patients with acute GVHD | 3 months | day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. |
Other
| Measure | Time frame | Description |
|---|---|---|
| tissue IHC stain level of biopsy samples of diagnosed acute GVHD | if patients diagnosed with acute GVHD will be performed random biopy of colon or stomach. | — |
| oral mucositis | 1 month | find-out the correlation HMGB1 level and oral mucositis grading |
Countries
South Korea
Contacts
Primary Contactyoung-woo JEON, bachelor, MD
Outcome results
None listed