Trial record 16 of 511 for:    hepatitis b | Open Studies

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01970254
First received: October 22, 2013
Last updated: July 8, 2016
Last verified: July 2016
  Purpose
The goal of this clinical research study is to learn about testing patients for viral infections before chemotherapy. Researchers want to learn which patients are at higher risk for these infections so that, in the future, patients might be able to be tested more effectively.

Condition Intervention
Cancer
Hepatitis B
HBV
Other: HBV screening tests
Behavioral: HBV risk assessment survey

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Widespread Versus Selective Screening for Hepatitis B Infection Prior to Chemotherapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Rate of a positive result (HBsAg, anti-HBc, and anti-HBs) before first chemotherapy [ Time Frame: Baseline blood tests, approximately 30 minutes for blood draw ] [ Designated as safety issue: No ]
    Number of screened participants (new cancer patients undergoing chemotherapy) with positive hepatitis B virus (HBV) infection compared to total screened. Prospective, universal screening of eligible MD Anderson cancer patients not known to have HBV infection using three HBV screening tests (HBsAg,anti-HBc,and anti-HBs) prior to chemotherapy.


Estimated Enrollment: 3441
Study Start Date: June 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatitis B Screening
Testing for positive hepatitis B virus (HBV) infection before chemotherapy using three HBV screening tests (HBsAg,anti-HBc,and anti-HBs) and survey completion.
Other: HBV screening tests
Three (3) hepatitis B virus (HBV) infection tests: HBsAg, anti-HBc, and anti-HBs
Behavioral: HBV risk assessment survey
Estimated time to complete the HBV risk assessment tool is 5 minutes.
Other Name: Questionnaire

  Hide Detailed Description

Detailed Description:

Enrollment Visit:

If you agree to take part in this study, the following tests and procedures will be performed at an enrollment visit:

  • Blood (about 1 tablespoon) will be drawn to test for hepatitis B, C, and HIV. However, if you are scheduled for a blood draw in the next 1-2 months, this can be done at that time. If this blood draw has been done within 90 days before enrollment, it will not be repeated.
  • You will fill out questionnaires about your risk of having hepatitis B, C, and HIV. You will also answer questions about your demographic information such as your age, race, and sex. This should take about 10 minutes to complete.
  • If your cancer doctor asks for information about your enrollment in the study, this will be provided to your cancer team.

Study Visit:

If the tests show you do not have hepatitis B, C, or HIV infection, you will be mailed a letter with the results of the testing.

If you are found to have hepatitis B, C, or HIV infection, the study staff will contact you and your cancer doctor. You will receive further evaluation by medical staff in the Departments of General Internal Medicine, Infectious Diseases, or Gastroenterology, Hepatology and Nutrition, to determine whether you need antiviral medication and further medical care during chemotherapy treatments. The study staff will inform your cancer doctor if you need antiviral medication. The study staff will work closely with your cancer doctor(s) to avoid any delays in treatment.

You may have the following tests and procedures at a baseline visit (about 4 weeks after enrollment) and at Months 3, 6, 9, 12, 15, and 18 (+/- 4 weeks):

  • If it has not been done in the last 2 weeks, blood (about 1-2 tablespoons) will be drawn for routine tests and to test for hepatitis B.
  • If the doctor thinks it is needed, you will be asked about any side effects and symptoms you may have had.

If the questionnaire shows that you may have had contact with someone who had hepatitis B, you may be contacted for further evaluation by medical staff in the Department of General Internal Medicine to determine whether you need further medical care during chemotherapy treatments. If the doctor thinks it is needed, blood (about 1-2 tablespoons) will be drawn for follow-up tests.

Length of Study:

If you do not have one of these infections, your active study participation will be over after the baseline visit.

If you have hepatitis B, hepatitis C, or HIV infection, you will remain on the study as long as you are benefiting, until 12 months after your chemotherapy treatment ends, or until the study closes. Researchers may continue to check your medical record for up to 18 months after study enrollment or for up to 12 months after your chemotherapy treatment ends. If you are still receiving chemotherapy when the study closes, you will have the option to continue with your care off of the study.

This is an investigational study. Researchers are investigating whether all patients or selective patients should be tested for hepatitis B, C, and HIV.

Up to 3,441 participants will be enrolled in this study. All will take part at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult cancer patients scheduled to receive chemotherapy in the Ambulatory Treatment Center (ATC) at The University of Texas (UT) MD Anderson Cancer Center.
Criteria

Inclusion Criteria:

  1. UNKNOWN HBV INFECTION STATUS/ KNOWN HBV INFECTION STATUS MD Anderson patients with clinically confirmed cancer who present for their first chemotherapy appointment in the Ambulatory Treatment Center (ATC).
  2. UNKNOWN HBV INFECTION STATUS/ KNOWN HBV INFECTION STATUS Patients >/= 18 years of age. (Patients < 18 years of age have low risk of HBV infection due to mandatory HBV vaccinations at birth.)
  3. KNOWN HBV INFECTION STATUS Patients with evidence of HBV infection by either: a. Patients who have had a positive HBsAg or anti-HBc test performed outside of MD Anderson within the last 3 months, and they have documented results in the electronic medical record at MD Anderson or, AND/OR b. Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other FDA-approved anti-hepatitis B drug) for the treatment of HBV infection.

Exclusion Criteria:

  1. UNKNOWN HBV INFECTION STATUS Patients who have had a positive HBsAg or anti-HBc test performed outside of MD Anderson within the last 3 months, and they have documented results in the electronic medical record at MD Anderson.
  2. UNKNOWN HBV INFECTION STATUS Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other FDA-approved anti-hepatitis B drug) for the treatment of HBV infection.
  3. KNOWN HBV INFECTION STATUS Exclusion: None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970254

Contacts
Contact: Jessica P. Hwang, MD 713-745-4516

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jessica P. Hwang, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Jessica P. Hwang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01970254     History of Changes
Other Study ID Numbers: 2012-0961  1R21CA167202-01A1 
Study First Received: October 22, 2013
Last Updated: July 8, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
hepatitis B virus infection
HBV
Cancer Patients
chemotherapy
HBV screening strategy
HBV care
chronic HBV
concomitant HBV infection
viral infections

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Infection
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 24, 2016