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

This study has been terminated.
(low enrollment low enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615628
First Posted: February 14, 2008
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University
  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:


Further study details as provided by Timothy Damron, M.D., State University of New York - Upstate Medical University:

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

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

Information from the National Library of Medicine

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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
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 Submitted: February 1, 2008
First Posted: February 14, 2008
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