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

NCT ID: NCT02044185

Last Updated: 2015-04-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

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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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

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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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Acute Graft-versus-host Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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high dose chemotherapy

group of using myeloablation regimen, autologous stell cell transplantation

salvage chemotherapy, total body irradiation

Intervention Type DRUG

there are no direct interventions to our patients.

control group

normal population with health screening

salvage chemotherapy, total body irradiation

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

1. very old age ( over 75-year-old)
2. patients with reduced intensity stem cell transplantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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JEON YOUNG-WOO

medical doctor, fellowship

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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young-woo JEON, bachelor, MD

Role: CONTACT

821042324067

Facility Contacts

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Hyo-jin KIM

Role: primary

822225880212

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.

Reference Type BACKGROUND
PMID: 22760779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19819342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22552293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23723299 (View on PubMed)

Other Identifiers

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CMC-SGC-Lymphoma-LAB-01

Identifier Type: -

Identifier Source: org_study_id

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