Trial record 12 of 15 for:    "multiple endocrine neoplasia"

Genetic Evaluation of Families With Endocrine Cancers (MEN1)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Rutgers University
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Alexander Shifrin, MD, FACS, FACE, Jersey Shore University Medical Center
ClinicalTrials.gov Identifier:
NCT01794676
First received: February 15, 2013
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Thymic Cancer
Parathyroid Disease
MEN1 Syndrome
Genetic: Blood draw

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: A Pilot Study of Genetic Evaluation of Families With Endocrine Cancers

Resource links provided by NLM:


Further study details as provided by Jersey Shore University Medical Center:

Primary Outcome Measures:
  • Modified genetic factors that exist and may influence the phenotypic presentation of disease in unrelated MEN 1 families. [ Time Frame: Within 3 Months from blood draw ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Approximately 10 ml of blood will be drawn from each participant. Tumor samples will be obtained from any prior surgeries, if available.


Estimated Enrollment: 25
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Family 1
Approximately a 10 ml of blood draw will be taken from each participant for genetic testing.
Genetic: Blood draw
Blood draw
Other Name: Blood draw
Family 2
Approximately a 10 ml of blood draw will be taken from each participant for genetic testing.
Genetic: Blood draw
Blood draw
Other Name: Blood draw
Family 3
Approximately a 10 ml of blood draw will be taken from each participant for genetic testing.
Genetic: Blood draw
Blood draw
Other Name: Blood draw

Detailed 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 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals belonging to families observed with MEN1 mutation related cancers.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794676

Locations
United States, New Jersey
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Jersey Shore University Medical Center
Rutgers University
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Alexander Shifrin, MD Jersey Shore University Medical Center
  More Information

No publications provided

Responsible Party: Alexander Shifrin, MD, FACS, FACE, Attending Endocrine Surgeon, Jersey Shore University Medical Center
ClinicalTrials.gov Identifier: NCT01794676     History of Changes
Other Study ID Numbers: IIU03-07, MEN1
Study First Received: February 15, 2013
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jersey Shore University Medical Center:
Pancreatic cancer
Thymic cancer
Parathyroid disease
MEN1 syndrome
Genomic DNA
MEN1 gene sequence

Additional relevant MeSH terms:
Multiple Endocrine Neoplasia Type 1
Multiple Endocrine Neoplasia
Pancreatic Neoplasms
Parathyroid Diseases
Endocrine Gland Neoplasms
Thymus Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Endocrine System Diseases
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases
Thoracic Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014