Bone Marrow-derived Cells' Contribution to Tumor Formation and Inflammation

NCT ID: NCT00452205

Last Updated: 2009-08-04

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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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 investigation(Y-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.

Conditions

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Gastrointestinal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* After allogeneic bone marrow transplantation

Exclusion Criteria

* Contraindication for gastrointestinal endoscopy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Komagome Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tokyo Metropolitan Komagome Hospital

Principal Investigators

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Naoto Egawa, MD

Role: STUDY_DIRECTOR

Locations

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Cancer and Infection Disease Center, Komagome

Tokyo, Bunkyo-ku, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Naoto Egawa, MD

Role: CONTACT

+81-3-3823-2101 ext. 6158

Hisashi Sakamaki, MD

Role: CONTACT

+81-3-3823-2101 ext. 6153

Facility Contacts

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Naoto Egawa, MD

Role: primary

+81-3-3823-2101 ext. 6158

Hisashi Sakamaki, MD

Role: backup

+81-3-3823-2101 ext. 6153

References

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Houghton J, Stoicov C, Nomura S, Rogers AB, Carlson J, Li H, Cai X, Fox JG, Goldenring JR, Wang TC. Gastric cancer originating from bone marrow-derived cells. Science. 2004 Nov 26;306(5701):1568-71. doi: 10.1126/science.1099513.

Reference Type BACKGROUND
PMID: 15567866 (View on PubMed)

Other Identifiers

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CICK-07521

Identifier Type: -

Identifier Source: org_study_id

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