NCT00472602

Brief Summary

Opisthorchis viverrini (OV) is a parasite that individuals get from eating raw fish. Infections with this parasite have been associated with liver abnormalities that sometimes lead to bile duct cancer. The purpose of this study is to find out how many people in several areas of the Khon Kaen province are infected with OV, what affect this parasite has on the liver, how the immune system reacts to infection with this parasite, and how the liver is 12 months after being treated for this parasite. Study participants will include 6,000 volunteers, ages 20-60, living in villages surrounding Khon Kaen that have large numbers of people infected with OV. Study procedures will include a stool sample, an ultrasound (sound waves bounced off internal organs to create a picture), and a blood sample. Individuals found to test positive for the parasite will be treated at their local primary health care unit. Participants will be involved in study procedures for up to 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
695

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2012

Completed
Last Updated

January 31, 2019

Status Verified

July 1, 2014

Enrollment Period

4.7 years

First QC Date

May 10, 2007

Last Update Submit

January 30, 2019

Conditions

Opisthorchis Viverrini

Keywords

Opisthorchis viverrini, liver fluke, Thailand, cancer

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females between 20 and 60 years of age, inclusive, infected with Opisthorchis viverrini
  • Willingness to participate in the study as evidenced by signing the informed consent document.

You may not qualify if:

  • Inability to correctly answer all questions on the informed consent comprehension questionnaire.
  • Attends school or works full-time outside of the study area.
  • Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
  • Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer to participate in the trial or would render the subject unable to comply with the protocol.
  • A positive urine Beta-hCG pregnancy test for females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

August 6, 2007

Primary Completion

April 30, 2012

Study Completion

April 30, 2012

Last Updated

January 31, 2019

Record last verified: 2014-07

Locations

TH(1)