Epidemiology Controls Using Healthy Participants | NCT00476632

Studies
Epidemiology Controls Using Healthy Participants

NCT00476632

Sponsor

M.D. Anderson Cancer Center

Status

Unknown status

Last Update Posted

May 10, 2019Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Questionnaire

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
P50CA100632	U.S. NIH Grant/Contract		View source
5R01CA070917-08	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

May 21, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

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 8, 2019

Last Update Posted Date

May 10, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.

Detailed Description

For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), certain environmental exposures, your medical history, family history, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview.

You will also have around 2 ½ tablespoons of blood drawn for special tests. These tests will look for any biologic factors associated with certain cancers. The interview and blood draw will be scheduled at the time and place of your convenience. You will not be informed of the results of any of the testing done with your samples.

There is a possibility that you might be contacted in the future about if researchers need clarification on any of information already collected. You are free to refuse any further participation if you wish.

This is an investigational study. Up to 1,500 participants will take part in this study.

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

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control		Person with no history of cancer.	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	50 Minute Interview	Control	Survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To identify biologic and lifestyle factors that may increase a person's risk of developing certain types of cancer.		6 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals ages 18 and over with no prior cancer
Willing and able to complete an administered questionnaire
Willing and able to donate 30 mL of blood

Exclusion Criteria:

Individuals with prior cancer
Individuals under the age of 18

Accepts Healthy Volunteers

Yes

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

Individuals 18 years or older with no history of cancer.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carrie Daniel-MacDougall, PHD	M.D. Anderson Cancer Center	Principal Investigator

Locations

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

References Module

Citations

Not provided

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms