Pancreatic Cancer Clinical Trial
Official title:
A Pilot Study of Genetic Evaluation of Families With Endocrine Cancers
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 pancreatic cancers, thymus gland cancers, parathyroid disease and MEN1 syndrome as low-risk and high-risk to improve screening and timing of surgery.
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
Rutgers University Cell & DNA Repository 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.
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