Molecular Epidemiology of Therapy-related Acute Myeloid L... | NCT00525746

Studies
Molecular Epidemiology of Therapy-related Acute Myeloid Leukemia/Myelodysplastic Syndrome (AML/MDS)

NCT00525746

Sponsor

M.D. Anderson Cancer Center

Status

Unknown status

Last Update Posted

Jan 14, 2020Actual

Enrollment

191Actual

Phase

Not provided

Conditions

Leukemia
Myelodysplastic Syndrome

Interventions

Interview

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

Jan 2020

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

Mar 31, 2006Actual

Primary Completion Date

Mar 31, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Sep 5, 2007

First Posted Date

Sep 6, 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

Jan 10, 2020

Last Update Posted Date

Jan 14, 2020Actual

Name	Class
National Cancer Institute (NCI)	NIH

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

The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing acute myeloid leukemia or myelodysplastic syndrome after treatment for a previous cancer (treatment-related AML/MDS).

Detailed Description

For this study, you will be asked to take part in a personal or mail interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), any chemicals you may have been exposed to, your medical history, family history of cancer, your diet, and your smoking and alcohol use histories. It should take around 50 minutes to complete the interview. Treatment information from your medical records at M. D. Anderson will also be collected.

You will be asked to provide a saliva sample or have around 1 tablespoon of blood drawn for special tests. These tests will look for biologic factors associated with treatment-related AML/MDS.

Your participation in this study will be over once the interview has been completed and blood or saliva have been collected.

This is an investigational study. Up to 600 participants will take part in this study. All will be enrolled at M. D. Anderson.

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

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients with a confirmed diagnosis of AML or MDS (cases).	Behavioral: Interview
Controls		Patients treated for a primary malignancy (controls).	Behavioral: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Behavioral	Interview lasting about 50 minutes.	Cases Controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epidemiologic, Clinical, + Constitutional Markers Associated with t-AML/MDS Development		3 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Willing and able to provide written informed consent and authorization
Willing to donate a saliva sample or 10 ml of blood and to complete a self-administered or personal interview
A histologically confirmed diagnosis of AML or MDS (cases only)
A history of a previous primary malignancy that was treated with chemotherapy and/or radiation therapy (cases only)
Enrolled in leukemia/MDS studies under protocol ID00-173 or ID03-0250 (cases only)
Treated for a primary malignancy at MDACC (controls only)
Matched to cases (2:1) by cases' prior malignancy(site, treatment (chemo and/or radiation), year of diagnosis (+/- 3 years)), age (+/- 5 years), sex, and ethnicity. (controls only)

Exclusion Criteria:

Under 18 years of age
History of second primary malignancy (controls only)

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

Participants, 18 years or older, with a confirmed diagnosis of AML or MDS (cases), or treated for a primary malignancy (controls).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jian Gu, 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

Label	URL
University of Texas MD Anderson Cancer Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D009190	Myelodysplastic Syndromes
D015470	Leukemia, Myeloid, Acute
D009369	Neoplasms

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D001855	Bone Marrow Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided