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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050762
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050762


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

Locations
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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
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Principal Investigator: Nancy D. Perrier, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03050762    
Other Study ID Numbers: PA11-0695
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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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:
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Adrenal Gland Diseases
Endocrine System Diseases