AzTrials
AzTrials

Acute Graft-versus-host DiseaseCHIP-SCTNCT02044185

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

An observational study of Acute Graft-versus-host Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Graft-versus-host Disease
What is being tested?
salvage chemotherapy, total body irradiation
How many people
100 participants
Where
1 siteSouth Korea
Study dates
Jan 2014to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

  1. Inclusion Criteria:
  2. over 18-year-old
  3. patients with myeloablative conditioning regimen
  4. autologous transplant
  5. patients with confirmation of acute GVHD as over grade II
  6. patients with salvage chemotherapy
  7. Exclusion Criteria:
  8. very old age ( over 75-year-old)
  9. patients with reduced intensity stem cell transplantation

Trial locations and contacts

1 site in 1 country.

young-woo JEON, bachelor, MD contact

821042324067

South Korea1 site, 1 recruiting

  • Seoul St.Mary's hospital

    Seoul, 137701

    Hyo-jin KIM, 822225880212, irbcumc@catholic.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the detailed description
  1. materials 1) inclusion criteria
  2. over 18-year-old
  3. patients with myeloablative conditioning regimen
  4. autologous transplant
  5. patients with confirmation of acute GVHD as over grade II
  6. patients with salvage chemotherapy
  7. exclusion criteria <!-- -->
  8. old age ( over 60-year-old)
  9. patients with reduced intensity stem cell transplantation
  10. 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)
  11. analysis 1) student t-test , chi-square test 2) survival analysis
Being tested
salvage chemotherapy, total body irradiation
Keywords
HMGB1 Protein, Graft versus Host Disease, Immunosuppressive Agents, oral mucositis
Medical subject headings
Graft vs Host Disease, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • salvage chemotherapy, total body irradiationDrug

    there are no direct interventions to our patients.

Study groups in NCT02044185
Study groupRoleWhat they receive
high dose chemotherapygroup of using myeloablation regimen, autologous stell cell transplantation
Receives: Drug: salvage chemotherapy, total body irradiation
control groupnormal population with health screening
Receives: Drug: salvage chemotherapy, total body irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (1)

  1. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02044185
Sponsor's protocol ID
CMC-SGC-Lymphoma-LAB-01
Acronym
CHIP-SCT
Status last verified
Apr 2015
First submitted
21 Jan 2014
Last updated
22 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22760779

  • 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.

    PubMed 19819342

  • 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.

    PubMed 22552293

  • 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.

    PubMed 23723299

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Graft-versus-host Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact young-woo JEON, bachelor, MD (821042324067), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison of serum HMGB1 level before and after diagnosed acute GVHD (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044185, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in