Multiple Endocrine NeoplasiaNCT03053999
Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
An observational study of Multiple Endocrine Neoplasia and Pancreatic Neuroendocrine Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Endocrine Neoplasia, Pancreatic Neuroendocrine Tumors, Hyperparathyroidism
- What is being tested?
- Genome Sequencing and Data Review
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2012to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants identified as follows: Patients of the Surgical team at MD Anderson Cancer Center who have undergone parathyroidectomy.
Who may be able to join
- MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
- MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.
Read the detailed description
Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.
- Being tested
- Genome Sequencing, Data Review
- Keywords
- Multiple Endocrine Neoplasia, Pancreatic Neuroendocrine Tumors, Hyperparathyroidism, HPTH, PNET, Biomarkers, Parathyroidectomy, Genome sequencing, Data review
- Medical subject headings
- Multiple Endocrine Neoplasia, Hyperparathyroidism, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genome SequencingOther
Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.
Data ReviewOther
Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).
| Study group | Role | What they receive |
|---|---|---|
| Parathyroidectomy Tissue and Data | Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.
Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels). Receives: Other: Genome Sequencing; Other: Data Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing
Measured: 10 years
Secondary outcomes (1)
Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Data Review
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start9 Oct 2012
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Endocrine NeoplasiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy D. Perrier, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053999
- Sponsor's protocol ID
- PA12-0892
- Status last verified
- Sep 2019
- First submitted
- 13 Feb 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
- ClinicalTrials.gov ID
- NCT03053999
- Acronym / sponsor ID
- PA12-0892
- Keywords
- Multiple Endocrine Neoplasia, Pancreatic Neuroendocrine Tumors, Hyperparathyroidism, HPTH, PNET, Biomarkers, Parathyroidectomy, Genome sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Oct 2012 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.
Detailed description
Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroidectomy Tissue and Data | – | Other: Genome Sequencing, Other: Data ReviewAnalyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors. Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants identified as follows: Patients of the Surgical team at MD Anderson Cancer Center who have undergone parathyroidectomy.
Key inclusion criteria (2 listed)
- MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
- MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genome SequencingAnalyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors. | Other | Parathyroidectomy Tissue and Data |
| Data ReviewClinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels). | Other | Parathyroidectomy Tissue and Data |
Primary outcome
Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing
Time frame: 10 years
1 secondary outcome
Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Data Review
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy D. Perrier, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Endocrine Neoplasia and Pancreatic Neuroendocrine Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy D. Perrier, MD (713-792-6940, NPerrier@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.