Genetic MutationNCT03043508
Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)
An observational study of Genetic Mutation and MEN1, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genetic Mutation, MEN1
- What is being tested?
- Chart Review and Questionnaire
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2015to 1 Apr 2026
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
- All patients for whom hormone status variables and survival data are available will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Genetic Mutation, MEN1
- Being tested
- Chart Review, Questionnaire
- Keywords
- Genetic mutation, MEN1, Pancreatic neuroendocrine tumor, PNET, Chart review, Questionnaire, Survey
- Medical subject headings
- Adenoma, Islet Cell, Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart ReviewOther
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.
QuestionnaireBehavioural
Also called Survey
Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chart Review; Behavioral: Questionnaire | |
| 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. Receives: Other: Chart Review; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Pancreatic Neuroendocrine Tumors (PNET)
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.
Measured: 10 years
Secondary outcomes (1)
Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET
Overall survival estimated and plotted using Kaplan-Meier method (Kaplan, 1958)(4).
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 posted6 Feb 2017 (estimated)
- Study start10 Apr 2015
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic MutationStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
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
- NCT03043508
- Sponsor's protocol ID
- PA15-0231
- Status last verified
- May 2019
- First submitted
- 2 Feb 2017
- Last updated
- 23 May 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 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall and Disease Specific Survival in Patients With Confirmed MEN1 With or Without PNET (Pancreatic Neuroendocrine Tumors)
- ClinicalTrials.gov ID
- NCT03043508
- Acronym / sponsor ID
- PA15-0231
- Conditions
- Genetic Mutation, MEN1
- Keywords
- Genetic mutation, MEN1, Pancreatic neuroendocrine tumor, PNET, Chart review, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 6 Feb 2017 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants With Confirmed MEN1 With PNET | – | Other: Chart Review, Behavioral: QuestionnaireRetrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history. |
| Participants With Confirmed MEN1 Without PNET | – | Other: Chart Review, Behavioral: QuestionnaireRetrospective review of a prospectively maintained MEN1 database. Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Patients with a diagnosis of MEN1 with or without PNET based on mutational analysis or defined clinical criteria were considered.
- All patients for whom hormone status variables and survival data are available will be included.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Chart ReviewDatabase 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. | Other | Participants With Confirmed MEN1 With PNET, Participants With Confirmed MEN1 Without PNET |
| QuestionnaireAlso: SurveyParticipants sent an email questionnaire to complete regarding their pregnancy and hormone use history. | Behavioural | Participants With Confirmed MEN1 With PNET, Participants With Confirmed MEN1 Without PNET |
Primary outcome
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.
1 secondary outcome
Overall Survival in Participants Who Have Confirmed MEN1 with or without PNET
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 23 May 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 Genetic Mutation and MEN1, 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 3 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 23 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Pancreatic Neuroendocrine Tumors (PNET) (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 23 May 2019.