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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02638402
Other study ID # 201405068RINA
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 20, 2015
Last updated May 11, 2016
Start date May 2016
Est. completion date August 2017

Study information

Verified date May 2016
Source National Taiwan University Hospital
Contact Chi-Hau Chen, MD, PhD
Phone +886-972651980
Email chihau@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Observational

Clinical Trial Summary

To clarify the critical role of glycosyltransferases, altered Mucins, and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases, Mucins and receptor tyrosin kinases (RTKs) family in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays.


Description:

Glycosylation is a widely utilized chemical modification of proteins and lipids in mammalian cells during which saccharide units are covalently attached to the target structures and then sequentially elongated and branched - reactions facilitated by a large number of various glycosyltransferases. Alterations in this process have been associated with malignant transformation. To clarify the critical role of glycosyltransferases, altered Mucins (MUC), and RTKs in human ovarian and endometrial neoplasms, the study will examine the immunohistochemical expression profiles of glycosyltransferases (including β-1,4-Galactosyltransferase 1 (B4GALT1), β-1,4-Galactosyltransferase 3 (B4GALT3), β-1,4-N-Acetyl-Galactosaminyl Transferase 3 (B4GALNT3), Polypeptide N-Acetylgalactosaminyltransferase 2 (GALNT2), Polypeptide N-Acetylgalactosaminyltransferase 6 (GALNT6), β1,4-N-acetylglucosaminyltransferase III (GlcNAcT-III), β1,4-N-acetylglucosaminyltransferase V (GlcNAcT-V), and Glycoprotein-N-Acetylgalactosamine 3-Beta-Galactosyltransferase 1 (C1GALT1), Mucins (including MUC1, MUC3, MUC15, and MUC20) and receptor tyrosin kinases (RTKs) family (including epidermal growth factor receptor (EGFR), Src, VEGFR, and c-Met) in various stages and/or histologic subtypes of human ovarian and endometrial neoplasms and tissue microarrays, and compare them with clinicopathologic factors including outcome of the patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date August 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Ovarian and endometrial cancer patients receiving operation in National Taiwan University Hospital

Exclusion Criteria:

- Recurrence or non-operable patients

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Measure the Immunohistochemistry (IHC) expression 5 years after patient received surgery No
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