Observational Study for Clinical Implications of HMGB1 (High-mobility Group Protein B1) in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- comparison of serum HMGB1 level before and after diagnosed acute GVHD
Study Overview
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
-
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
- 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
high dose chemotherapy
group of using myeloablation regimen, autologous stell cell transplantation
Intervention: salvage chemotherapy, total body irradiation (Drug)
control group
normal population with health screening
Intervention: salvage chemotherapy, total body irradiation (Drug)
Outcomes
Primary Outcomes
comparison of serum HMGB1 level before and after diagnosed acute GVHD
Time Frame: 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 Outcomes
- serum level of immunosuppressive drugs in patients with acute GVHD(3 months)
Investigators
JEON YOUNG-WOO
medical doctor, fellowship
Seoul St. Mary's Hospital