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Trial #NCT01794676

Pancreatic Cancer Clinical Trials

Genetic Evaluation of Families With Endocrine Cancers


A Pilot Study of Genetic Evaluation of Families With Endocrine Cancers
Study ID: IIU03-07; Secondary ID: MEN1; Source: Jersey Shore University Medical Center
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Enrolling by invitation
Country United States
Study type Observational
Enrollment 25
Start date March 2013
Completion date June 2013
Phase N/A
Sponsor Jersey Shore University Medical Center
Summary:
This study is being conducted to identify altered genetic factors that may exist and
influence endocrine cancers in unrelated MEN1 families with different cancers. A grading
system will be developed for endocrine cancers, including thyroid cancer, pancreatic
cancers, thymus gland cancers, parathyroid disease and MEN1 syndrome as low-risk and
high-risk to improve screening and timing of surgery.
Description:
Participants will be sent a personal medical questionnaire and family history questionnaire
to complete prior to their visit. Participants will meet with a genetic counselor
face-to-face for up to 120 minutes to complete a personal and family history. Participants
will receive genetic counseling including education about MEN1 syndrome and recommendations
for the management of this disease. The genetic counselor will also assist participants
with coping mentally. The genetic counselor will review the risk, benefits and limitations
of genetic testing.

After study eligibility is confirmed and the participant agrees to participate in the study,
approximately 10 ml (2 teaspoons) of blood will be taken from the participant for genetic
testing. Tumor samples from any prior surgeries will be requested from the Jersey Shore
University Medical Center pathology department for review.

The participant's blood sample and any tumor samples will be assigned a unique identifier.
Participants will not be identified by name. This identifier, along with the participant's
age, sex, ethnicity and if applicable, age of cancer diagnosis (or MEN1 syndrome diagnosis)
will be kept at Jersey Shore University Medical Center research department. Medical records
will be reviewed for demographics, known cancer risk factors, family history, age and stage
at diagnosis of disease, tumor characteristics, previous and current treatments, medication
history, test and study results, and pathology/surgery reports. Blood and tumor samples
will be sent to the Functional Genomics Facility at The Cancer Institute of New Jersey and
Sequencing and Microarray Core Facility at Princeton University for processing and/or
analysis to identify the genetic pattern in patients at risk for MEN1.

The result of the genetic test for the MEN1 gene will be provided to the participant by
either the genetic counselor or study doctor. The genetic counselor or study doctor will
interrupt the results for the participant and provide emotional support, if necessary. The
results of any altered genes will not be disclosed to the participant.

Medical records will be reviewed annually to determine the status of the participant's
disease, if any. Participants will be contacted directly by phone or in person at
follow-up clinic visit(s) for the collection of information not recorded in the
participant's medical record for up to 20 years.
Eligibility:
Gender: Both
Age: 13 Years - N/A
Eligibility Criteria:
- Age = 13 years.
- A signed written informed consent
- Existing patients and their family members of Investigators with MEN1 syndrome.
- Willing to undergo venipuncture to obtain 10 ml of blood and complete genetic counseling and informed consent process.
Outcome:
Primary outcome
  • Modified genetic factors that exist and may influence the phenotypic presentation of disease in unrelated MEN 1 families.
    To identify modifying genetic factors that exist and that may influence phenotypic presentation of the disease in unrelated MEN 1 families with different clinical presentation of the disease.
    Time frame: Within 3 Months from blood draw
Contacts:
  • Alexander Shifrin, MD; Jersey Shore University Medical Center (Principal Investigator)
Location Country Status
Jersey Shore University Medical Center Neptune, New Jersey United States
Sponsors:
  • Jersey Shore University Medical Center - (Lead Sponsor)
  • Princeton University - Collaborator
  • Cancer Institute of New Jersey - Collaborator
Related trials: Terms
  • MEN1 syndrome
  • Genomic DNA
  • Pancreatic cancer
  • MEN1 gene sequence
  • Parathyroid disease
  • Thymic cancer
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