Genetic Susceptibility to Kidney Cancer | NCT00854022

Studies
Genetic Susceptibility to Kidney Cancer

NCT00854022

Sponsor

Baylor College of Medicine

Status

Terminated

Last Update Posted

Feb 25, 2020Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

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 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding ended

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Feb 26, 2009

First Submission Date that Met QC Criteria

Feb 27, 2009

First Posted Date

Mar 2, 2009Estimated

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 21, 2020

Last Update Posted Date

Feb 25, 2020Actual

Name	Class
M.D. Anderson Cancer Center	OTHER

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

This study will further the understanding of the genetic events leading to the development of RCC.

Detailed Description

This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy adults, of any ethnicity, or sex, and with no previous history of cancer, except for non-melanoma skin cancer
RCC		Adult patients with newly diagnosed (diagnosed within the year of enrollment) renal carcinoma (RCC) any ethnicity, or sex, who have not received prior chemotherapy or radiotherapy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To identify interindividual differences in inherited genetic instability		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of any ethnicity or sex, who have a been diagnosed with possible Renal Cell Carcinoma within the past year.

Exclusion Criteria:

Must not have received chemotherapy, biological therapy or radiation therapy in the 6 months preceding enrollment will
Must not have had RCC, or metastatic RCC,
Must not have had a renal transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with newly diagnosed (diagnosed within the year of enrollment) with possible Renal Cell Carcinoma (RCC)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seth P. Lerner, MD	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Description

We will utilize the blood collected to run several laboratory analyses that will assess DNA damage/repair, telomere length, telomerase activity, and other genetic instability as predictors of RCC risk. All information linking this unique identifier to the participant will be kept in a secure location under lock-and-key password protected.

In addition, RCC tumor and adjacent normal tissue samples may be obtained from the MDACC Institutional Tissue Bank (ITB) for cases only. The samples obtained will be left over from surgical procedures, so as to prevent any additional distress to the patient.