NCT00160472

Brief Summary

This study will evaluate the expression of arginine vasopressin (AVP) by peptide and mRNA quantitation and also measurement of its V1 receptor mRNA, in the arteries and veins of ovarian malignant (cancerous) or benign (non-cancerous) tissue. The investigators will examine whether AVP protein and AVP and V1 receptor mRNA expression vary with respect to tumor histology, intratumoral vascularization and systemic blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 26, 2010

Status Verified

March 1, 2004

Enrollment Period

4.8 years

First QC Date

September 8, 2005

Last Update Submit

February 25, 2010

Conditions

Ovarian Neoplasms

Keywords

vasopressinovarianneoplasm

Outcome Measures

Primary Outcomes (3)

  • Compare the levels of AVP and the vasopressin V1 receptor expression in the arteries and veins of ovarian tissue found to be cancerous versus ovarian tissue found to be noncancerous

  • Correlate the expression of AVP and its V1 receptor to stage of ovarian neoplasms graded by histology assessment

  • Correlate the expression of AVP and its receptor to intratumoral vascularization through Doppler ultrasound and systemic blood pressure.

Interventions

removal of ovarian vesselsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who have had gynecologic tissue removed for benign (noncancerous) or malignant (cancerous) indications.

You may not qualify if:

  • Patients who have a malignancy that is not a primary gynecologic malignancy.
  • Age less than 18
  • Males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsDiabetes InsipidusNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPituitary Diseases

Study Officials

  • John H Farley, MD

    Uniformed Services Unievrsity of the Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 26, 2010

Record last verified: 2004-03

Locations

US(1)