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Gastrointestinal NeoplasmsNCT00452205

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

An observational study of Gastrointestinal Neoplasms, run by Komagome Hospital at 1 site in Japan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Gastrointestinal Neoplasms
How many people
300 participants
Where
1 siteJapan
Study dates
Apr 2007to Mar 2017
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients received bone marrow transplantation in Tokyo Metropolitan Komagome Hospital

Who may be able to join

  • After allogeneic bone marrow transplantation

Who cannot join

  • Contraindication for gastrointestinal endoscopy

Trial locations and contacts

1 site in 1 country.

Japan1 site, 1 recruiting
  • Cancer and Infection Disease Center, Komagome

    Tokyo, Bunkyo-ku, 113-8677

    Naoto Egawa, MD, +81-3-3823-2101 ext. 6158, naoto@cick.jp

    Hisashi Sakamaki, MD, +81-3-3823-2101 ext. 6153, sakamaki@cick.jp

    Recruiting

Other trials in Japan

About this study

Official title: Bone Marrow-derived Cells' Contribution to Tumor Formation and Epithelial Cells Regeneration in the Gastrointestinal Tract

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.

Read the 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 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.
Keywords
bone marrow-derived stem cell, bone marrow transplantation, graft versus host disease, gastrointestinal cancer, after receiving bone marrow transplantation
Medical subject headings
Gastrointestinal Neoplasms, Graft vs Host Disease

Timeline

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

  1. First posted27 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Study completionMar 2017 (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
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452205
Sponsor's protocol ID
CICK-07521
Status last verified
Aug 2009
First submitted
26 Mar 2007
Last updated
4 Aug 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15567866

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Neoplasms, run by Komagome Hospital at 1 site in Japan.

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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 4 Aug 2009. 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 Japan. 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 Naoto Egawa, MD (+81-3-3823-2101 ext. 6158, naoto@cick.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452205, which also lists 1 linked publication.

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 4 Aug 2009.

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