Expired Study
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Syracuse, New York 13202


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.


Study summary:

As above, no additional information


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


Study is Available At:


Original ID:

Osteosarcoma & Paget'


NCT ID:

NCT00615628


Secondary ID:

IRB #4168


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

State University of New York - Upstate Medical University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

low enrollment low enrollment


Study Type:

Observational


Study Design:

Observational Model: Family-Based, Time Perspecti


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Timothy A Damron, MD
Principal Investigator
State University of New York - Upstate Medical University

Study Dates

Start Date:April 2002
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 29, 2013
First Received Date:February 1, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Loss of heterozygosity
Time Frame:January, 2000 through February 2009
Safety Issues:False
Description:A loss of heterozygosity of a proposed tumor suppressor gene on chromosome 18

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:family members
Description:family members of the proband and father identified

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:State University of New York - Upstate Medical University

Samples and Retentions

Sample Retention:Samples With DNA
Description: 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
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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