Inheritance of Osteosarcoma & Paget's Disease Through Chr... | NCT00615628

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

NCT00615628

Sponsor

State University of New York - Upstate Medical University

Status

Terminated

Last Update Posted

May 30, 2013Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Osteosarcoma
Paget's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB #4168	Other Identifier	IRB number

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment low enrollment

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2013

Last Update Posted Date

May 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Damron, M.D., Associate Professor, State University of New York - Upstate Medical UniversityPrincipal Investigator

Lead Sponsor

State University of New York - Upstate Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

As above, no additional information

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8Actual

Label	Type	Description	Intervention Names
family members		family members of the proband and father identified

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Loss of heterozygosity	A loss of heterozygosity of a proposed tumor suppressor gene on chromosome 18	January, 2000 through February 2009

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Upstate Medical University		Syracuse	New York	13202	United States

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma
D010001	Osteitis Deformans

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

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