NCT00615628

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

7.7 years

First QC Date

February 1, 2008

Last Update Submit

May 29, 2013

Conditions

Keywords

Inheritance of Osteosarcoma & Paget's Disease through Chromosome 18

Outcome Measures

Primary Outcomes (1)

  • Loss of heterozygosity

    A loss of heterozygosity of a proposed tumor suppressor gene on chromosome 18

    January, 2000 through February 2009

Study Arms (1)

family members

family members of the proband and father identified

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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.
  • Not part of the family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13202, United States

Location

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

MeSH Terms

Conditions

OsteosarcomaOsteitis Deformans

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaBone DiseasesMusculoskeletal Diseases

Study Officials

  • Timothy A Damron, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

April 1, 2002

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations