Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
4 other identifiers
observational
2,206
1 country
1
Brief Summary
This trial studies hepatitis B screening strategies of new cancer patients scheduled to undergo chemotherapy. Patients with cancer and hepatitis B virus infection are at risk of reactivation of infection after chemotherapy. Hepatitis B virus infection reactivation can be prevented by starting antivirals before chemotherapy in patients who are hepatitis B virus infection positive. Hepatitis B screening may help doctors prevent the reactivation of hepatitis B virus infection after chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2013
CompletedFirst Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2022
CompletedAugust 15, 2022
August 1, 2022
9.1 years
October 22, 2013
August 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of a positive result (hepatitis B surface antigen [HBsAg], hepatitis B core antibody [anti-HBc], and hepatitis B surface antibody [anti-HBs]) before first chemotherapy
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.
Baseline blood tests, approximately 30 minutes for blood draw
Study Arms (1)
Screening (hepatitis B screening)
Patients with unknown HBV infection status undergo 3 HBV screening tests (HBsAg, anti-HBc, and anti-HBs) before chemotherapy. Patients with known HBV infection status undergo either HBsAg or anti-HBc screening tests if there is no evidence of HBV testing in the last 3 months. All patients complete HBV risk assessment survey.
Interventions
Undergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs)
Eligibility Criteria
MD Anderson patients with clinically confirmed cancer who present for their first chemotherapy appointment in the Ambulatory Treatment Center
You may qualify if:
- 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).
- KNOWN HBV INFECTION STATUS: Patients with evidence of HBV infection by either:
- 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, AND/OR
- Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other Federal Drug Administration \[FDA\]-approved anti-hepatitis B drug) for the treatment of HBV infection.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica P Hwang
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 28, 2013
Study Start
June 24, 2013
Primary Completion
July 19, 2022
Study Completion
July 19, 2022
Last Updated
August 15, 2022
Record last verified: 2022-08