Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452205
Status:
UNKNOWN
Last Update Posted:
2009-08-04
First Post:
2007-03-26
Brief Title:
Bone Marrow-derived Cells Contribution to Tumor Formation and Inflammation
Sponsor:
Komagome Hospital
Organization:
Komagome Hospital
Study Overview
Official Title:
Bone Marrow-derived Cells Contribution to Tumor Formation and Epithelial Cells Regeneration in the Gastrointestinal Tract
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
RECRUITING
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:
The purpose of this study is to clarify the relationship bone marrow-derived cells and the formation of the tumors and the role of these cells in regeneration of epithelial cells in the gastrointestinal tract
Detailed Description:
Recent experimental studies showed that circulating bone marrow-derived stem cells contribute to the formation of cancers cells However it is not clear whether this is applicable to human beings or not In addition bone marrow-derived cells are considered to play a significant role in regeneration of inflamed epithelial cells of the gastrointestinal tract during graft versus host disease GVHD which sometimes occurs after bone marrow transplantation BMT On the other hand it is well known that the incidence of solid tumors is significantly increased following bone marrow transplantation
One purpose of this study is to determine the role of bone marrow-derived cells in the tumor formation and acute or chronic inflammation of the gastrointestinal tract in human beings and the other is to discover early cancers of the gastrointestinal tract in the subjects received BMT by conducting surveillance for detecting second tumor periodically
All subjects are the patients received allogeneic BMT in Tokyo Metropolitan Komagome Hospital for hematopoietic disorders
For determining the role of bone marrow-derived cells in the solid tumors and inflammation like GVHD suitable candidates are females who received allogeneic BMT from male donors because the most reliable marker of bone marrow-derived cells is identification of the Y chromosomes from the male donor in the tissue of female
For the early detection of gastrointestinal cancers the subjects are confined to patients without recurrence of original disorder at least 1 year after BMT They are scheduled to undergo a medical inspection using gastrointestinal endoscopy periodically
When tumor or any other lesions are discovered biopsy specimens are taken and proceed to pathological examination According to the results the patients will have proper treatments
The tissue specimens from the tumors or inflammation in female recipients from male donors are processed for Y fluorescent in situ hybridization FISH analysis and immunocytochemistry using monoclonal antibodies such as cytokeratin CD45 and so on
Procedure
First of all informed consent to this study should be gained from the subjects
Study 1 to determine the role of bone marrow-derived cells on inflammation such as GVHD
1 Subjects are female recipients from male donors
2 When they have some symptoms suggesting acute or chronic GVHD gastrointestinal endoscopy is conducted and biopsy specimens are taken from the lesions for the definite diagnosis and identification of bone marrow-derived cells
3 Pathological investigationY-FISH etc is conducted using the tissue specimens
Study 2 to conduct surveillance for second malignancy and to determine the role of bone marrow-derived cells on the formation of the tumor
1 Subjects are confined to bone marrow recipients without the recurrence of the original disorder at least 1 year after BMT
2 A medical inspection for gastrointestinal tract is performed using periodical endoscopy
3 The tissue from tumors or any other lesions discovered are taken as biopsy specimen and processed for pathological examination Regarding the female recipients from male donors the same procedure as in the study 1 is taken for pathological study
One purpose of this study is to determine the role of bone marrow-derived cells in the tumor formation and acute or chronic inflammation of the gastrointestinal tract in human beings and the other is to discover early cancers of the gastrointestinal tract in the subjects received BMT by conducting surveillance for detecting second tumor periodically
All subjects are the patients received allogeneic BMT in Tokyo Metropolitan Komagome Hospital for hematopoietic disorders
For determining the role of bone marrow-derived cells in the solid tumors and inflammation like GVHD suitable candidates are females who received allogeneic BMT from male donors because the most reliable marker of bone marrow-derived cells is identification of the Y chromosomes from the male donor in the tissue of female
For the early detection of gastrointestinal cancers the subjects are confined to patients without recurrence of original disorder at least 1 year after BMT They are scheduled to undergo a medical inspection using gastrointestinal endoscopy periodically
When tumor or any other lesions are discovered biopsy specimens are taken and proceed to pathological examination According to the results the patients will have proper treatments
The tissue specimens from the tumors or inflammation in female recipients from male donors are processed for Y fluorescent in situ hybridization FISH analysis and immunocytochemistry using monoclonal antibodies such as cytokeratin CD45 and so on
Procedure
First of all informed consent to this study should be gained from the subjects
Study 1 to determine the role of bone marrow-derived cells on inflammation such as GVHD
1 Subjects are female recipients from male donors
2 When they have some symptoms suggesting acute or chronic GVHD gastrointestinal endoscopy is conducted and biopsy specimens are taken from the lesions for the definite diagnosis and identification of bone marrow-derived cells
3 Pathological investigationY-FISH etc is conducted using the tissue specimens
Study 2 to conduct surveillance for second malignancy and to determine the role of bone marrow-derived cells on the formation of the tumor
1 Subjects are confined to bone marrow recipients without the recurrence of the original disorder at least 1 year after BMT
2 A medical inspection for gastrointestinal tract is performed using periodical endoscopy
3 The tissue from tumors or any other lesions discovered are taken as biopsy specimen and processed for pathological examination Regarding the female recipients from male donors the same procedure as in the study 1 is taken for pathological study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None