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Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18:

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ClinicalTrials.gov Identifier: NCT00615628
Recruitment Status : Terminated (low enrollment low enrollment)
First Posted : February 14, 2008
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University

Study Description
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Brief Summary:
Researchers have previously demonstrated loss of heterozygosity in a region on chromosome 18q, associated with osteogenic sarcomas in bone affected by Paget's disease. The loci used in this study are specifically described by those authors as showing loss of heterozygosity in 6 of 7 affected families.

Condition or disease
Osteosarcoma Paget's Disease

Detailed Description:
As above, no additional information

Study Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Inheritance of Osteosarcoma & Paget's Disease Through Chromosome 18: Examination of Osteosarcoma Tissue Samples From Two Family Members for Loss of Heterozygosity in the Chromosome 18 Region, Genetically Linked With Paget's Disease of Bone
Study Start Date : April 2002
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Groups and Cohorts
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Group/Cohort
family members
family members of the proband and father identified


Outcome Measures
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Primary Outcome Measures :
  1. Loss of heterozygosity [ Time Frame: January, 2000 through February 2009 ]
    A loss of heterozygosity of a proposed tumor suppressor gene on chromosome 18


Biospecimen Retention:   Samples With DNA
Once a specimen is obtained DNA will be isolated for paraffin-embedded tissue and peripheral blood. Osteosarcoma samples from paraffin embedded, formalin-fixed post-surgical tissue samples will be obtained for the proband and father. Matched normal spamples will be obtained from these individuals as adjacent normal tissue from the post-surgical specimens

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18. The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son.
Criteria

Inclusion Criteria:

  • This is a familial study therefore the only inclusion/exclusion criteria would be that subjects must be a blood relative and over the age of 18.
  • The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son.

Exclusion Criteria:

  • Not part of the family
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615628


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Timothy A Damron, MD State University of New York - Upstate Medical University
More Information
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Responsible Party: Timothy Damron, M.D., Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00615628     History of Changes
Other Study ID Numbers: Osteosarcoma & Paget's Disease
IRB #4168 ( Other Identifier: IRB number )
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Timothy Damron, M.D., State University of New York - Upstate Medical University:
Inheritance of Osteosarcoma & Paget's Disease through Chromosome 18

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma