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Chile Biliary Longitudinal Study

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ClinicalTrials.gov Identifier: NCT02692911
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

The gallbladder is a small organ below the liver. Gallbladder cancer is a leading cause of cancer death among women in Chile. Chile also has among the highest rates of gallbladder cancer and death in the world. Researchers in a high-risk region of Chile want to find out more about this type of cancer. They especially want to know how inflammation affects the way it develops.

Objective:

To better understand the causes of gallbladder diseases and factors that may be associated with them.

Eligibility:

Women ages 50 74 with gallbladder cancer who are covered by the Chilean national health system.

Other people over age 21 with gallbladder disease.

Healthy adults over age 21.

Design:

Participants may be screened with an ultrasound. They may be asked questions about their health.

Participants will have an ultrasound of the abdomen. This can be done at the study clinic or in the hospital or at home. The ultrasound uses sound waves to take pictures of the gallbladder.

Participants will have a physical exam.

Participants will have their mouths looked at for tooth loss, dentures, and gum redness.

Participants will give a blood sample or saliva sample.

Participants will be asked for access to their medical history. They may be asked to allow researchers to keep any samples taken during gallbladder surgery.

Participants will answer questions about their medical history. This will include illnesses, surgeries, medicine use, and family history. It will also include diet and lifestyle habits, such as places where they have lived and worked.

Some participants will have 3 follow-up visits over 6 years.


Condition or disease
Gallbladder Cancer Nutritional and Metabolic Diseases

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 35000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chile Biliary Longitudinal Study
Study Start Date : February 25, 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort
Women with gallstones
Women aged 50-74 with gallstones



Primary Outcome Measures :
  1. Cancer/precancer [ Time Frame: during course of the study ]
    Our major exposures of interest are patterns, levels, and changes in inflammatory markers and ultrasound characteristics, with Gallbladder Dysplasia and Cancer as the primary outcome of interest.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subject identification will begin with a census of the target neighborhoods in Chile in the study areas. Potential participants will be contacted by study staff (healthcare assistants), who will conduct home visits. If participant is eligible, study staff will invite the individual to participate and obtain written informed consent. She will then schedule an appointment at the study center for the screening ultrasound and give her the instructions to prepare for the examination.
Criteria
  • INCLUSION CRITERIA:

General Population Cohort:

  • Female
  • Age 50 years to 74 years
  • No previous cholecystectomy
  • Covered by National Health Insurance
  • Resident of Araucania (or Maule)
  • Able to answer questionnaire (due to language/communication issues or mental incapacity)

Other control (general population or cholecystectomy):

  • No previous cholecystectomy
  • Covered by National Health Insurance
  • Resident of Araucania (or Maule)
  • Able to answer questionnaire (due to language/communication issues or mental incapacity)

Gallbladder Cancer Group:

  • Diagnosis within study time period
  • Primary site of cancer is the gallbladder with histological or radiological confirmation
  • Covered by National Health Insurance
  • Resident of Araucania (or Maule)
  • Able to answer questionnaire (due to language/communication issues or mental incapacity)

EXCLUSION CRITERIA:

General Population Cohort:

  • Male
  • Age less than 50 years or greater than 74 years
  • History of previous cholecystectomy
  • Not covered by National Health Insurance
  • Not a Resident of Araucania (or Maule)
  • Unable to answer questionnaire (due to language/communication issues or mental incapacity)

Other control (general population or cholecystectomy):

  • History of previous cholecystectomy
  • Not covered by National Health Insurance
  • Not a Resident of Araucania (or Maule)
  • Unable to answer questionnaire (due to language/communication issues or mental incapacity)

Gallbladder Cancer Group:

  • Diagnosis not within study time period
  • Primary site of cancer is NOT the gallbladder with histological or radiological confirmation
  • Not covered by National Health Insurance
  • Not a Resident of Araucania (or Maule)
  • Unable to answer questionnaire (due to language/communication issues or mental incapacity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692911


Contacts
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Contact: Jill E. Koshiol, M.D. (301) 402-9508 jk516n@nih.gov

Locations
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Chile
Hospital Regional de Talca Recruiting
Talca, Chile
Universidad Catolica del Maule Recruiting
Talca, Chile
Hospital Regional de Temuco Recruiting
Temuco, Chile
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jill E. Koshiol, M.D. National Cancer Institute (NCI)

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02692911     History of Changes
Other Study ID Numbers: 999916070
16-C-N070
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 12, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gallbaldder
Cancer
Gallstones
Cholecystectomy
Inflammation

Additional relevant MeSH terms:
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Metabolic Diseases
Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases