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

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

Study Overview

• Status: Recruiting
• Conditions: Endocrine Disease
• Intervention / Treatment: Other: Data Collection; Behavioral: Follow Up

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.

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Nancy D. Perrier, MD; Phone Number: 713-792-6940; Email: NPerrier@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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.
2. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participant information collected from either source document or direct participant response.; Behavioral: Follow Up; Participants followed up at the return to clinic visits. If participant cannot come to clinic, either a questionnaire mailed requesting follow-up, or participant called. Participants followed for a length of 15 years at intervals of every 2-3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Nancy D. Perrier, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2011
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Database; Parathyroid disease; Thyroid disease; Data Review; Endocrine Disease; Adrenal disease
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases
• Other Study ID Numbers: PA11-0695

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No