Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
NCT ID: NCT02044185
Last Updated: 2015-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2014-01-31
2015-12-31
Brief Summary
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Detailed Description
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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
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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high dose chemotherapy
group of using myeloablation regimen, autologous stell cell transplantation
salvage chemotherapy, total body irradiation
there are no direct interventions to our patients.
control group
normal population with health screening
salvage chemotherapy, total body irradiation
there are no direct interventions to our patients.
Interventions
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salvage chemotherapy, total body irradiation
there are no direct interventions to our patients.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. patients with reduced intensity stem cell transplantation
18 Years
75 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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JEON YOUNG-WOO
medical doctor, fellowship
Principal Investigators
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seok-goo CHO, M.D,Ph.D
Role: STUDY_CHAIR
The Catholic University of Korea
Locations
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Seoul St.Mary's hospital
Seoul, , South Korea
Countries
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Central Contacts
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young-woo JEON, bachelor, MD
Role: CONTACT
Facility Contacts
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References
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Brennan TV, Lin L, Huang X, Cardona DM, Li Z, Dredge K, Chao NJ, Yang Y. Heparan sulfate, an endogenous TLR4 agonist, promotes acute GVHD after allogeneic stem cell transplantation. Blood. 2012 Oct 4;120(14):2899-908. doi: 10.1182/blood-2011-07-368720. Epub 2012 Jul 3.
Kornblit B, Masmas T, Petersen SL, Madsen HO, Heilmann C, Schejbel L, Sengelov H, Muller K, Garred P, Vindelov L. Association of HMGB1 polymorphisms with outcome after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2010 Feb;16(2):239-52. doi: 10.1016/j.bbmt.2009.10.002. Epub 2009 Oct 9.
Jube S, Rivera ZS, Bianchi ME, Powers A, Wang E, Pagano I, Pass HI, Gaudino G, Carbone M, Yang H. Cancer cell secretion of the DAMP protein HMGB1 supports progression in malignant mesothelioma. Cancer Res. 2012 Jul 1;72(13):3290-301. doi: 10.1158/0008-5472.CAN-11-3481. Epub 2012 May 2.
Kang R, Zhang Q, Zeh HJ 3rd, Lotze MT, Tang D. HMGB1 in cancer: good, bad, or both? Clin Cancer Res. 2013 Aug 1;19(15):4046-57. doi: 10.1158/1078-0432.CCR-13-0495. Epub 2013 May 30.
Other Identifiers
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CMC-SGC-Lymphoma-LAB-01
Identifier Type: -
Identifier Source: org_study_id
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