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Trial record 37 of 312 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT01970254
Recruitment Status : Recruiting
First Posted : October 28, 2013
Last Update Posted : January 8, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cancer Hepatitis B HBV Other: HBV screening tests Behavioral: HBV risk assessment survey

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Study Design

Study Type : Observational
Estimated Enrollment : 3441 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Widespread Versus Selective Screening for Hepatitis B Infection Prior to Chemotherapy
Study Start Date : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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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): 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 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

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