Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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materials 1) inclusion criteria over 18-year-old patients with myeloablative conditioning regimen autologous transplant patients with confirmation of acute GVHD as over grade II patients with salvage chemotherapy 2) exclusion criteria old age ( over 60-year-old) patients with reduced intensity stem cell transplantation 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) analysis 1) student t-test , chi-square test 2) survival analysis

Official Title
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Observational Study for Clinical Implications of HMGB1 (High-mobility Group Protein B1) in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation

Conditions
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Acute Graft-versus-host Disease

Intervention / Treatment
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* Drug: salvage chemotherapy, total body irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18-year-old patients with myeloablative conditioning regimen autologous transplant patients with confirmation of acute GVHD as over grade II patients with salvage chemotherapy Exclusion Criteria: very old age ( over 75-year-old) patients with reduced intensity stem cell transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high dose chemotherapy<br>group of using myeloablation regimen, autologous stell cell transplantation | Drug: salvage chemotherapy, total body irradiation<br>* there are no direct interventions to our patients.<br>|
| control group<br>normal population with health screening | Drug: salvage chemotherapy, total body irradiation<br>* there are no direct interventions to our patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of serum HMGB1 level before and after diagnosed acute GVHD | day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of immunosuppressive drugs in patients with acute GVHD | day 7 before stem cell transplantation(SCT), day 0, day 7, 14 after SCT, and date of diagnosed acute GVHD in all patients. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMGB1 Protein, Graft versus Host Disease, Immunosuppressive Agents, oral mucositis