Comprehensive Data Collection and Follow-Up for Patients... | NCT03050762

Studies
Comprehensive Data Collection and Follow-Up for Patients With Thyroid, Parathyroid and Adrenal Disease

NCT03050762

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Sep 17, 2019Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Endocrine Disease

Interventions

Data Collection
Follow Up

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2011Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Feb 9, 2017

First Submission Date that Met QC Criteria

Feb 10, 2017

First Posted Date

Feb 13, 2017Actual

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

Sep 13, 2019

Last Update Posted Date

Sep 17, 2019Actual

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 data review study is to collect data to learn more about thyroid, parathyroid, and adrenal disease.

Detailed Description

If participant or participant's child agrees to take part in this study, information from the medical record will be recorded and entered into a research database at MD Anderson. Researchers will use this data to learn more about participant's or participant's child's current or suspected illness, surgery, and/or recovery as well as participant's or participant's child's medical history.

Length of Study Participant's or participant's child's active participation on this study will be over after 15 years.

Follow-Up Phone Calls Starting about 2-3 years after participant's or participant's child's testing and/or diagnosis and/or treatment and continuing for up to 15 years after participant's surgery, a member of the research team will contact participant by phone to follow up and see how participant or participant's child are doing. The first time participant receives a phone call or are asked in the clinic, participant will be asked for participant's verbal consent for participant or, if this is for participant's child, on behalf of participant's child, to speak to the member of the research team before participant or participant's child are asked any questions. After participant agrees, participant or participant's child will be asked a series of questions related to participant's or participant's child's disease (takes about 20-30 minutes) that ask about participant's or participant's child's current medical status and medical history. Each phone call should take 20-30 minutes to complete.

If participant or participant's child are scheduled for a routine clinic visit around the time of participant's or participant's child's next follow-up phone call, the research team member may talk to participant or participant's child in person at that time, or a questionnaire can be mailed to participant or participant's child if needed.

This is an investigational study.

Up to 15,000 patients will be enrolled in this study. All will be enrolled at MD Anderson.

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

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endocrine Disease Group		Information from the medical record recorded and entered into a research database. Starting about 2-3 years after testing and/or diagnosis and/or treatment and continuing for up to 15 years after surgery, research team will contact participant by phone to follow up.	Other: Data Collection Behavioral: Follow Up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data Collection	Other	Participant information collected from either source document or direct participant response.	Endocrine Disease Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Research Database Compilation from Suspected or Diagnosed Endocrine Disease Participants by Medical Record Review and Follow Up	Database compiled from continuous collection of data on patients diagnosed with surgical endocrine disease or patients who are at risk for developing endocrine neoplasia and/or disease, and by prospective follow-ups of patient populations.	15 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients that are being seen at MD Anderson with diagnosed or suspected endocrine disease. Patients will be selected from patients undergoing evaluation and/or treatment in the Endocrine Center, either by selection from a participating Endocrine physician or by screening from study personnel for patients scheduled to be seen in the Endocrine Clinic.
In addition, we intend to contact family members of patients who are enrolled on the study, and found to be deceased at follow-up, to request permission to obtain cause of death, to determine whether cause of death may be related to endocrine disease.

Exclusion Criteria:

N/A

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

Participants seen at MD Anderson Cancer Center with diagnosed or suspectied endocrine disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nancy D. Perrier, MD	Contact	713-792-6940		NPerrier@mdanderson.org

Overall Officials

Name	Affiliation	Role
Nancy D. Perrier, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

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

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

Condition Browse Module

MeSH Terms

ID	Term
D004700	Endocrine System Diseases
D013959	Thyroid Diseases
D010279	Parathyroid Diseases
D000307	Adrenal Gland Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided