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Trial record 3 of 1327 for:    survival | Neuroendocrine Tumors

Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)

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ClinicalTrials.gov Identifier: NCT03043508
Recruitment Status : Active, not recruiting
First Posted : February 6, 2017
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

OBJECTIVES:

The primary objective of this study is to evaluate the effect of estrogen on the development of the PNET in MEN1 patients.

The secondary objective is to evaluate the overall survival and disease specific survival in patients who have confirmed MEN1 with or without PNET and a pancreatic neuroendocrine tumor in relation to their hormone status. The secondary objective is to evaluate clinicopathologic features in relation to hormone status.


Condition or disease Intervention/treatment
Genetic Mutation MEN1 Other: Chart Review Behavioral: Questionnaire

Detailed Description:

Retrospective review of a prospectively maintained MEN1 database. The patient cohort consists of all patients with confirmed MEN1 with or without PNET who are included in the database. The database will be reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

For the prospective portion of this study, investigators want to see the impact of estrogen on the PNET forming and progression, and would like to use two equations to assess the estrogen exposure, so investigators should collect the information of menopause, menarche, breast feed, HRT, OCP use and pregnancy. To this end, investigators will contact female patients in the database who are still living, and obtain verbal informed consent to send an email questionnaire regarding their pregnancy and hormone use history.


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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)
Actual Study Start Date : April 10, 2015
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2026


Group/Cohort Intervention/treatment
Participants With Confirmed MEN1 With PNET

Retrospective review of a prospectively maintained MEN1 database.

Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Other: Chart Review
Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

Behavioral: Questionnaire
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Other Name: Survey

Participants With Confirmed MEN1 Without PNET

Retrospective review of a prospectively maintained MEN1 database.

Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.

Other: Chart Review
Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.

Behavioral: Questionnaire
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
Other Name: Survey




Primary Outcome Measures :
  1. Time to Pancreatic Neuroendocrine Tumors (PNET) [ Time Frame: 10 years ]
    Time to PNET calculated starting from the date of menarche time to the PNET diagnostic date or the menopause date (for the patients who get the menopause prior to the PNET diagnosis) or the last follow-up date.


Secondary Outcome Measures :
  1. Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET [ Time Frame: 10 years ]
    Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospectively maintained MEN1 database within the Department of Surgical Oncology, Division of Surgical Endocrinology at the University of Texas MD Anderson Cancer Center.
Criteria

Inclusion Criteria:

  1. The patient cohort for this study consists of all patients within the prospectively maintained MEN1 database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
  2. Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
  3. All patients for whom hormone status variables and survival data are available will be included.

Exclusion Criteria:

1. Due to the nature of the questions included in the prospective estrogen questionnaire, only female patients will be verbally consented to receive the questionnaire and obtain prospective data.


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): NCT03043508


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
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: NCT03043508     History of Changes
Other Study ID Numbers: PA15-0231
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 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:
Genetic mutation
MEN1
Pancreatic neuroendocrine tumor
PNET
Chart review
Questionnaire
Survey
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Multiple Endocrine Neoplasia Type 1
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Adenoma, Islet Cell
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs