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Trial record 65 of 2732 for:    Neoplasms | Neuroendocrine Tumors

Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)

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ClinicalTrials.gov Identifier: NCT03053999
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Condition or disease Intervention/treatment
Multiple Endocrine Neoplasia Pancreatic Neuroendocrine Tumors Hyperparathyroidism Other: Genome Sequencing Other: Data Review

Detailed Description:
Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.

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Study Type : Observational
Estimated Enrollment : 53 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
Actual Study Start Date : October 9, 2012
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023


Group/Cohort Intervention/treatment
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).

Other: Genome Sequencing
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.

Other: Data Review
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).




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study participants identified as follows: Patients of the Surgical team at MD Anderson Cancer Center who have undergone parathyroidectomy.
Criteria

Inclusion Criteria:

  1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
  2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.

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): NCT03053999


Contacts
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Contact: Nancy D. Perrier, MD 713-792-6940

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: NCT03053999     History of Changes
Other Study ID Numbers: PA12-0892
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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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:
Multiple Endocrine Neoplasia
Pancreatic Neuroendocrine Tumors
Hyperparathyroidism
HPTH
PNET
Biomarkers
Parathyroidectomy
Genome sequencing
Data review

Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Hyperparathyroidism
Adenoma, Islet Cell
Parathyroid Diseases
Endocrine System Diseases
Adenoma
Digestive System Diseases
Pancreatic Diseases
Genetic Diseases, Inborn