Opisthorchis ViverriniNCT00472602
Pathogenesis of Liver Fluke Induced Cancer in Thailand
An observational study of Opisthorchis Viverrini, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Opisthorchis Viverrini
- How many people
- 695 participants
- Where
- 1 siteThailand
- Study dates
- 6 Aug 2007to 30 Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Liver fluke infection caused by Opisthorchis viverrini (OV) is a major public health problem in parts of East Asia. In Thailand, an estimated 6 million are people infected with OV. Experimental and epidemiological evidence strongly implicate OV infection in the etiology of cholangiocarcinoma (CCA). Studies have shown 10-20% of OV-infected persons have advanced periportal fibrosis (HBA) that progresses to CCA. OV infection may cause inflammation of the bile ducts that results in DNA damage of the epithelium and subsequent malignant transformation. The primary objective of this study is to determine if in-vitro levels of inflammatory cytokines induced by crude antigen extracts of OV are associated with the hepatobiliary abnormalities known to progress to CCA in OV-infected adults aged 20 to 60 years of age. The secondary objective is to determine if in-vitro levels of inflammatory cytokines induced by crude antigen extracts of OV in adults with hepatobiliary abnormalities change 12 months after treatment with praziquantel and if these changes are associated with persistent advanced fibrosis (grade 2 or 3) as determined by ultrasonography. The primary outcome measure is elevated levels of inflammatory cytokines (such as TNF-alpha) induced by OV infection are associated with a 50% greater risk (OR = 1.50) of having advanced fibrosis (grade 2 or 3) as determined by ultrasonography. The secondary outcome measure is elevated levels of inflammatory cytokines 12 months after treatment for OV infection are associated with a 50% greater risk (OR = 1.50) of maintaining the advanced fibrosis that is known to progress to CCA over this time period. District health outposts reporting greater than or equal to 20 percent prevalence of OV infection among adults will be identified, whereupon males and females, 20 to 60 years of age, will be screened for OV infection. Study sites in Thailand will be districts of Ban Pai, Chonnabot, Muncha Khiri and Kok Pochai, regions along the drainage of the Chi River, in the vicinity of the regional capitol, Khon Kaen city. A recruitment ceiling of 20,000 individuals will be established to screen for infection with OV, with 6,000 enrolled in the observational and longitudinal parts of the study. OV-infected individuals will receive an ultrasound examination that will be graded as either HBA positive (advanced fibrosis) or HBA negative (non-advanced fibrosis). Over a 24 month period, 1,116 OV-infected individuals who are HBA positive will be recruited. The first 484 OV-infected individuals with HBA will be age and sex matched with OV-infected individuals from the same region who are HBA negative. Blood samples will be drawn from all volunteers and used in immunological evaluations of OV infection in relation to HBA status. This will constitute the observation stage of the study. The 1,116 OV-infected individuals with HBA will be followed for an additional 12 months, with an ultrasound exam and a blood draw. This will constitute the longitudinal stage of the study. All volunteers will then be treated for OV infection with praziquantel.
- Conditions
- Opisthorchis Viverrini
- Keywords
- Opisthorchis viverrini, liver fluke, Thailand, cancer
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study start6 Aug 2007
- Primary completion30 Apr 2012
- Study completion30 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opisthorchis ViverriniStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472602
- Sponsor's protocol ID
- 06-0001
- Status last verified
- Jul 2014
- First submitted
- 10 May 2007
- Last updated
- 31 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Liver Fluke Induced Cancer in Thailand
- ClinicalTrials.gov ID
- NCT00472602
- Acronym / sponsor ID
- 06-0001
- Conditions
- Opisthorchis Viverrini
- Keywords
- Opisthorchis viverrini, liver fluke, Thailand, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 6 Aug 2007
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2012 (actual)
- First posted
- 11 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Liver fluke infection caused by Opisthorchis viverrini (OV) is a major public health problem in parts of East Asia. In Thailand, an estimated 6 million are people infected with OV. Experimental and epidemiological evidence strongly implicate OV infection in the etiology of cholangiocarcinoma (CCA). Studies have shown 10-20% of OV-infected persons have advanced periportal fibrosis (HBA) that progresses to CCA. OV infection may cause inflammation of the bile ducts that results in DNA damage of the epithelium and subsequent malignant transformation. The primary objective of this study is to determine if in-vitro levels of inflammatory cytokines induced by crude antigen extracts of OV are associated with the hepatobiliary abnormalities known to progress to CCA in OV-infected adults aged 20 to 60 years of age. The secondary objective is to determine if in-vitro levels of inflammatory cytokines induced by crude antigen extracts of OV in adults with hepatobiliary abnormalities change 12 months after treatment with praziquantel and if these changes are associated with persistent advanced fibrosis (grade 2 or 3) as determined by ultrasonography. The primary outcome measure is elevated levels of inflammatory cytokines (such as TNF-alpha) induced by OV infection are associated with a 50% greater risk (OR = 1.50) of having advanced fibrosis (grade 2 or 3) as determined by ultrasonography. The secondary outcome measure is elevated levels of inflammatory cytokines 12 months after treatment for OV infection are associated with a 50% greater risk (OR = 1.50) of maintaining the advanced fibrosis that is known to progress to CCA over this time period. District health outposts reporting greater than or equal to 20 percent prevalence of OV infection among adults will be identified, whereupon males and females, 20 to 60 years of age, will be screened for OV infection. Study sites in Thailand will be districts of Ban Pai, Chonnabot, Muncha Khiri and Kok Pochai, regions along the drainage of the Chi River, in the vicinity of the regional capitol, Khon Kaen city. A recruitment ceiling of 20,000 individuals will be established to screen for infection with OV, with 6,000 enrolled in the observational and longitudinal parts of the study. OV-infected individuals will receive an ultrasound examination that will be graded as either HBA positive (advanced fibrosis) or HBA negative (non-advanced fibrosis). Over a 24 month period, 1,116 OV-infected individuals who are HBA positive will be recruited. The first 484 OV-infected individuals with HBA will be age and sex matched with OV-infected individuals from the same region who are HBA negative. Blood samples will be drawn from all volunteers and used in immunological evaluations of OV infection in relation to HBA status. This will constitute the observation stage of the study. The 1,116 OV-infected individuals with HBA will be followed for an additional 12 months, with an ultrasound exam and a blood draw. This will constitute the longitudinal stage of the study. All volunteers will then be treated for OV infection with praziquantel.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opisthorchis Viverrini, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.