Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation (CHIP-SCT)

April 21, 2015 updated by: JEON YOUNG-WOO, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: young-woo JEON, bachelor, MD
  • Phone Number: 821042324067

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. patients with bone marrow transplantation of patients with acute leukemia, lymphoma in patients group
  2. normal populations in Health Promotion Center in control group

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum level of immunosuppressive drugs in patients with acute GVHD
Time Frame: 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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue IHC stain level of biopsy samples of diagnosed acute GVHD
Time Frame: if patients diagnosed with acute GVHD will be performed random biopy of colon or stomach.
if patients diagnosed with acute GVHD will be performed random biopy of colon or stomach.
oral mucositis
Time Frame: 1 month
find-out the correlation HMGB1 level and oral mucositis grading
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Investigators

  • Study Chair: seok-goo CHO, M.D,Ph.D, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-SGC-Lymphoma-LAB-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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