Trial record 23 of 435 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 August 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01970254
First received: October 22, 2013
Last updated: August 14, 2014
Last verified: August 2014
  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 2015 (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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Investigators
Study Chair: Jessica P. Hwang, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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: August 14, 2014
Health Authority: United States: Institutional Review Board

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
Communicable Diseases
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 September 18, 2014