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

This study has been terminated.

(low enrollment low enrollment)

Sponsor:

Information provided by (Responsible Party):

Timothy Damron, M.D., State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT00615628

First received: February 1, 2008

Last updated: May 29, 2013

Last verified: May 2013

History of Changes

Purpose

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
Osteosarcoma Paget's Disease


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

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: Bone Cancer Osteosarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:

Loss of heterozygosity [ Time Frame: January, 2000 through February 2009 ] [ Designated as safety issue: No ]
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


Enrollment:	8
Study Start Date:	April 2002
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

As above, no additional information

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 1, 2008
Last Updated:	May 29, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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