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

• ClinicalTrials.gov Identifier: NCT03050762
• Recruitment Status: Recruiting
• First Posted: February 13, 2017
• Last Update Posted: September 17, 2019
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Endocrine Disease	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 Design

• Study Type: Observational
• Estimated Enrollment: 15000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comprehensive Data Collection and Follow-Up for Patients With Thyroid, Parathyroid and Adrenal Disease
• Actual Study Start Date: October 5, 2011
• Estimated Primary Completion Date: October 2026
• Estimated Study Completion Date: October 2027

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Research Database Compilation from Suspected or Diagnosed Endocrine Disease Participants by Medical Record Review and Follow Up [ Time Frame: 15 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Contacts

Contact: Nancy D. Perrier, MD; 713-792-6940; NPerrier@mdanderson.org

Locations

United States, Texas

University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

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

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT03050762
• Other Study ID Numbers: PA11-0695
• First Posted: February 13, 2017
• Last Update Posted: September 17, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:

Endocrine Disease; Thyroid disease; Parathyroid disease; Adrenal disease; Data Review; Database

Additional relevant MeSH terms:

Adrenal Gland Diseases; Endocrine System Diseases