Pancreatic Cancer Clinical Trial
— MEN1Official title:
A Pilot Study of Genetic Evaluation of Families With Endocrine Cancers
Verified date | June 2017 |
Source | Jersey Shore University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | October 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Jersey Shore University Medical Center | Neptune City | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Jersey Shore University Medical Center | Rutgers Cancer Institute of New Jersey, Rutgers University |
United States,
1) Multiple Endocrine Neoplasia Type 1 (MEN1) Syndrome. Marini F, Falchetti A, Luzi E, Tonelli F, Maria Luisa B. In: Riegert-Johnson DL, Boardman LA, Hefferon T, Roberts M, editors. Cancer Syndromes [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2009-.2008 Jul 18 2) Multiple endocrine neoplasia. White ML, Doherty GM. Surg Oncol Clin N Am. 2008 Apr;17(2):439-59 3) Multiple endocrine neoplasia type 1 (MEN1). Thakker RV. Best Pract Res Clin Endocrinol Metab. 2010 Jun; 4) Guidelines for diagnosis and therapy of MEN type 1 and type 2. Brandi ML, Gagel RF, Angeli A, Bilezikian JP, Beck-Peccoz P, Bordi C, Conte-Devolx B, Falchetti A, Gheri RG, Libroia A, Lips CJ, Lombardi G, Mannelli M, Pacini F, Ponder BA, Raue F, Skogseid B, Tamburrano G, Thakker RV, Thompson NW, Tomassetti P, Tonelli F, Wells SA Jr, Marx SJ. J Clin Endocrinol Metab. 2001 Dec;86(12):5658-71. 5) Multiple endocrine neoplasia type 1 (MEN1) germline mutations in familial isolated primary hyperparathyroidism. Pannett AA, Kennedy AM, Turner JJ, Forbes SA, Cavaco BM, Bassett JH, Cianferotti L, Harding B, Shine B, Flinter F, Maidment CG, Trembath R, Thakker RV. Clin Endocrinol (Oxf). 2003 May;58(5):639-46. 6) Human Gene Mutation Database, http://www.hgmd.org/ 6) Human Gene Mutation Database, http://www.hgmd.org/ 7) Familial isolated primary hyperparathyroidism caused by mutations of the MEN1 gene. Hannan FM, Nesbit MA, Christie PT, Fratter C, Dudley NE, Sadler GP, Thakker RV. Nat Clin Pract Endocrinol Metab. 2008 Jan; 8) Familial isolated hyperparathyroidism: clinical and genetic characteristics of 36 kindreds. Simonds WF, James-Newton LA, Agarwal SK, Yang B, Skarulis MC, Hendy GN, Marx SJ. Medicine (Baltimore). 2002 Jan;81(1):1-26. 9) Genotype-phenotype analysis in multiple endocrine neoplasia type 1. Kouvaraki MA, Lee JE, Shapiro SE, Gagel RF, Sherman SI, Sellin RV, Cote GJ, Evans DB. Arch Surg. 2002 Jun;137(6):641-7.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Within 3 Months from blood draw |
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