Study Investigating MEN1 and SDHD in Familial Carcinoid T... | NCT00672269

Studies
Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors

NCT00672269

Sponsor

Rutgers University

Status

Unknown status

Last Update Posted

Feb 4, 2009Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Carcinoid Neuroendocrine Cancer

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

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

May 2, 2008

First Submission Date that Met QC Criteria

May 5, 2008

First Posted Date

May 6, 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

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

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

There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

Detailed Description

This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Label	Type	Description	Intervention Names
1		Families with carcinoid in multiple family members

Measure	Description	Time Frame
Mutations in MEN1 and SDHD genes		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over the age of 18 years
More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
English speaking
Mentally and emotionally capable of answering questions
Willing and available for study participation
At least one other family member with carcinoid tumor

Exclusion Criteria:

If you are under the age of 18 years,
If you are unable to understand or unable to provide informed consent,
If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nancy Gardner, PhD	Contact	813-731-0894		gardnern@rutgers.edu
Changshun Shao, PhD	Contact			Shao@Biology.Rutgers.Edu

Overall Officials

Name	Affiliation	Role
Nancy Gardner, PhD	Rutgers University	Principal Investigator
Changshun Shao, PhD	Rutgers University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Busch Campus of Rutgers University, Human Genetics Institute	Recruiting	Piscataway	New Jersey	08854-8082	United States

Condition Browse Module

MeSH Terms

ID	Term
D002276	Carcinoid Tumor
D009369	Neoplasms

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Blood: a small sample of 2 tubes (2 - 4 teaspoons, or 20 ml). One tube will be used to prepare the DNA (your genetic material) for the test. The other would be used for further gene evaluation. The DNA will be stored with Rutgers University Cell and DNA Repository (RUCDR).