Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-31 @ 11:05 PM
Study NCT ID:
NCT00452205
Status:
UNKNOWN
Last Update Posted:
2009-08-04
First Post:
2007-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Marrow-derived Cells' Contribution to Tumor Formation and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2007-03-26', 'studyFirstSubmitQcDate': '2007-03-26', 'lastUpdatePostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone marrow-derived stem cell', 'bone marrow transplantation', 'graft versus host disease', 'gastrointestinal cancer', 'after receiving bone marrow transplantation'], 'conditions': ['Gastrointestinal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '15567866', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOne 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.\n\nAll subjects are the patients received allogeneic BMT in Tokyo Metropolitan Komagome Hospital for hematopoietic disorders.\n\nFor 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.\n\nFor 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.\n\nWhen 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.\n\nThe 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.\n\nProcedure\n\nFirst of all, informed consent to this study should be gained from the subjects.\n\nStudy 1: to determine the role of bone marrow-derived cells on inflammation such as GVHD\n\n1. Subjects are female recipients from male donors.\n2. 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.\n3. Pathological investigation(Y-FISH etc.) is conducted using the tissue specimens.\n\nStudy 2: to conduct surveillance for second malignancy and to determine the role of bone marrow-derived cells on the formation of the tumor\n\n1. Subjects are confined to bone marrow recipients without the recurrence of the original disorder at least 1 year after BMT.\n2. A medical inspection for gastrointestinal tract is performed using periodical endoscopy.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients received bone marrow transplantation in Tokyo Metropolitan Komagome Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* After allogeneic bone marrow transplantation\n\nExclusion Criteria:\n\n* Contraindication for gastrointestinal endoscopy'}, 'identificationModule': {'nctId': 'NCT00452205', 'briefTitle': "Bone Marrow-derived Cells' Contribution to Tumor Formation and Inflammation", 'organization': {'class': 'OTHER', 'fullName': 'Komagome Hospital'}, 'officialTitle': "Bone Marrow-derived Cells' Contribution to Tumor Formation and Epithelial Cells Regeneration in the Gastrointestinal Tract", 'orgStudyIdInfo': {'id': 'CICK-07521'}}, 'contactsLocationsModule': {'locations': [{'zip': '113-8677', 'city': 'Tokyo', 'state': 'Bunkyo-ku', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Naoto Egawa, MD', 'role': 'CONTACT', 'email': 'naoto@cick.jp', 'phone': '+81-3-3823-2101', 'phoneExt': '6158'}, {'name': 'Hisashi Sakamaki, MD', 'role': 'CONTACT', 'email': 'sakamaki@cick.jp', 'phone': '+81-3-3823-2101', 'phoneExt': '6153'}, {'name': 'Naoto Egawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer and Infection Disease Center, Komagome', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Naoto Egawa, MD', 'role': 'CONTACT', 'email': 'naoto@cick.jp', 'phone': '+81-3-3823-2101', 'phoneExt': '6158'}, {'name': 'Hisashi Sakamaki, MD', 'role': 'CONTACT', 'email': 'sakamaki@cick.jp', 'phone': '+81-3-3823-2101', 'phoneExt': '6153'}], 'overallOfficials': [{'name': 'Naoto Egawa, MD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Komagome Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Naoto Egawa', 'oldOrganization': 'Tokyo Metropolitan Komagome Hospital'}}}}