Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00092235
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2004-09-21
Brief Title:
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
Status:
RECRUITING
Status Verified Date:
2024-10-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Chronic graft-versus-host disease cGVHD is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation alloHSCT It is characterized by immune dysregulation immunodeficiency impaired organ function and decreased survival
Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant alloHSCT in North America and about 50 of patients who are transplanted develop cGVHD
Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation
Objectives
To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD
To prospectively identify clinical and biological prognostic markers in patients with cGVHD
To develop clinically relevant cGVHD grading scales
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation
To identify potential clinical and biological markers of cGVHD activity
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects
To identify potential patients for cGVHD treatment protocols at the NCI and NIH
Eligibility
-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis
Design
Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic
Minimally invasive biopsies and rarely deep tissue biopsy may be obtained to confirm the diagnosis andor rule-out other pathologic process in adults only
Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible
Chronic graft-versus-host disease cGVHD is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation alloHSCT It is characterized by immune dysregulation immunodeficiency impaired organ function and decreased survival
Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant alloHSCT in North America and about 50 of patients who are transplanted develop cGVHD
Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation
Objectives
To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD
To prospectively identify clinical and biological prognostic markers in patients with cGVHD
To develop clinically relevant cGVHD grading scales
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation
To identify potential clinical and biological markers of cGVHD activity
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects
To identify potential patients for cGVHD treatment protocols at the NCI and NIH
Eligibility
-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis
Design
Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic
Minimally invasive biopsies and rarely deep tissue biopsy may be obtained to confirm the diagnosis andor rule-out other pathologic process in adults only
Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible
Detailed Description:
Background
Chronic graft-versus-host disease cGVHD is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation alloHSCT It is characterized by immune dysregulation immunodeficiency impaired organ function and decreased survival
Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant alloHSCT in North America and about 50 of patients who are transplanted develop cGVHD
Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation
Objectives
To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD
To prospectively identify clinical and biological prognostic markers in patients with cGVHD
To develop clinically relevant cGVHD grading scales
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation
To identify potential clinical and biological markers of cGVHD activity
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects
To identify potential patients for cGVHD treatment protocols at the NCI and NIH
Eligibility
-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis
Design
Patient undergoes initial clinical and laboratory multi-specialty work-up at the NCI cGVHD clinic
Minimally invasive biopsies and rarely deep tissue biopsy may be obtained to confirm the diagnosis andor rule-out other pathologic process in adults only
Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible
Chronic graft-versus-host disease cGVHD is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation alloHSCT It is characterized by immune dysregulation immunodeficiency impaired organ function and decreased survival
Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant alloHSCT in North America and about 50 of patients who are transplanted develop cGVHD
Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation
Objectives
To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD
To prospectively identify clinical and biological prognostic markers in patients with cGVHD
To develop clinically relevant cGVHD grading scales
To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation
To identify potential clinical and biological markers of cGVHD activity
To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects
To identify potential patients for cGVHD treatment protocols at the NCI and NIH
Eligibility
-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis
Design
Patient undergoes initial clinical and laboratory multi-specialty work-up at the NCI cGVHD clinic
Minimally invasive biopsies and rarely deep tissue biopsy may be obtained to confirm the diagnosis andor rule-out other pathologic process in adults only
Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0281 | None | None | None |