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

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


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Paget disease of bone Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia Juvenile Paget disease

Genetic and Rare Diseases Information Center resources: Osteosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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, Older Adult
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

Information from the National Library of Medicine

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


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

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