NCT00173407

Brief Summary

We have identified insulin-like growth factor binding protein (IGFBP)-3 as an invasion suppressor gene in ovarian endometrioid carcinoma, and showed association with lower cancer migration, invasion and metastasis. Recently, a novel model of ovarian EC formation from endometriosis was reported, and PTEN was found to be a major protein involved. Inactivation of PTEN has been reported in some ovarian EC tumors and methylation was suggested as one of the major epigenetic changes. This tumorigenesis model has lots of similarity to our established invasion model. Therefore, we plan to study the important of PTEN expression in ovarian EC and if inactivation of PTEN and IFGBP-3 is through methylation. Furthermore, by studying the signal transduction pathways using PTEN and IGFBP-3 transfection, we plan to study the mutual interaction between PTEN and IGFBP-3 on the suppression of tumor invasion in ovarian EC.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

6.8 years

First QC Date

September 12, 2005

Last Update Submit

December 26, 2012

Conditions

Keywords

Ovarian endometrioid carcinomainvasionIGFBP-3transfectionsignal transductionPTENmethylation

Outcome Measures

Primary Outcomes (3)

  • migration

  • invasion

  • metastasis

Secondary Outcomes (3)

  • Immunohistochemical staining

  • methylation

  • signal tranduction

Interventions

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of ovarian endometrioid carcinoma

You may not qualify if:

  • other types of ovarian epithelial carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10020, Taiwan

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Methylation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

AlkylationBiochemical PhenomenaChemical PhenomenaOrganic Chemistry PhenomenaMetabolism

Study Officials

  • Torng Pao-Ling, MD, PhD

    Department of Obstetric and Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 27, 2012

Record last verified: 2012-12

Locations