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Protocol Summary


Protocol No.
PSHCI-14-071
Prinicipal Investigator
Warrick, Joshua
Phase
NA
Age Group
Adult
Scope
Local
Secondary Protocol No.
IRB # 00000840
Title
Exon Sequencing of Cancer Associated Genes in Endometrial Hyperplasia
Objective
Primary Study Endpoints
The primary endpoint is to determine if a series of endometrial hyperplasias found prior to a diagnosis of endometrioid adenocarcinoma of the uterus harbors mutations in the most commonly mutated genes found in endometrioid adenocarcinoma (e.g. PTEN, PIK3CA, KRAS, ARID1A, others). Associated is the endpoint to determine if endometrial hyperplasia that resolves spontaneously does no harbor mutations in these genes.
Secondary Study Endpoints
Once mutations in endometrial hyperplasia have been identified by exon sequencing, the corresponding endometrioid adenocarcinoma (if present) will be evaluated for these specific mutations by Sanger sequencing, to determine the clonal relationship between endometrial hyperplasia and the associated carcinoma.
Applicable Disease Sites
Corpus Uteri
Status
Open
Participating Institutions
Hershey Medical Center
Contact
Name
Joshua Warrick
Phone No.
+1 717-531-8246
E-mail
jiw11@psu.edu