CancerNCT01970254
Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
An observational study of Cancer and Hepatitis B, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hepatitis B, HBV
- What is being tested?
- Hepatitis B Screening and Survey Administration
- How many people
- 2,206 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2013to 19 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson patients with clinically confirmed cancer who present for their first chemotherapy appointment in the Ambulatory Treatment Center
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To derive a selective screening strategy that optimizes the identification of positive hepatitis B virus (HBV) infection cases in comparison to widespread screening of new cancer patients undergoing chemotherapy.
SECONDARY OBJECTIVES:
- To determine the prevalence of risk factors among patients with unknown HBV infection status as well as among patients known to have HBV infection, determine the incidence of reactivation of hepatitis B virus (HBV) infection, rates of disruptions in cancer therapy, co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV), and mortality rates.
OUTLINE:
Patients with unknown HBV infection status undergo 3 HBV screening tests (hepatitis B surface antigen [HBsAg], hepatitis B core antibody [anti-HBc], and hepatitis B surface antibody [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.
After completion of study, patients with HBV infection are followed up every 3 months for at least 12 months after completion of chemotherapy or end of study period.
- Conditions
- Cancer, Hepatitis B, HBV, Hepatitis B Infection, Malignant Neoplasm
- Being tested
- Hepatitis B Screening, Survey Administration
- Keywords
- hepatitis B virus infection, HBV, Cancer Patients, chemotherapy, HBV screening strategy, HBV care, chronic HBV, concomitant HBV infection, viral infections
- Medical subject headings
- Neoplasms, Hepatitis B, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B ScreeningOther
Undergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs)
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hepatitis B Screening; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline blood tests, approximately 30 minutes for blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study start24 Jun 2013
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica P Hwang, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970254
- Sponsor's protocol ID
- 2012-0961
- Other IDs
- NCI-2019-02247, 2012-0961, P30CA016672, R21CA167202
- Status last verified
- Aug 2022
- First submitted
- 22 Oct 2013
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
- ClinicalTrials.gov ID
- NCT01970254
- Acronym / sponsor ID
- 2012-0961
- Conditions
- Cancer, Hepatitis B, HBV, Hepatitis B Infection, Malignant Neoplasm
- Keywords
- hepatitis B virus infection, HBV, Cancer Patients, chemotherapy, HBV screening strategy, HBV care, chronic HBV, concomitant HBV infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,206 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Jun 2013 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To derive a selective screening strategy that optimizes the identification of positive hepatitis B virus (HBV) infection cases in comparison to widespread screening of new cancer patients undergoing chemotherapy.
SECONDARY OBJECTIVES:
- To determine the prevalence of risk factors among patients with unknown HBV infection status as well as among patients known to have HBV infection, determine the incidence of reactivation of hepatitis B virus (HBV) infection, rates of disruptions in cancer therapy, co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV), and mortality rates.
OUTLINE:
Patients with unknown HBV infection status undergo 3 HBV screening tests (hepatitis B surface antigen [HBsAg], hepatitis B core antibody [anti-HBc], and hepatitis B surface antibody [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.
After completion of study, patients with HBV infection are followed up every 3 months for at least 12 months after completion of chemotherapy or end of study period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (hepatitis B screening) | – | Other: Hepatitis B Screening, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson patients with clinically confirmed cancer who present for their first chemotherapy appointment in the Ambulatory Treatment Center
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis B ScreeningUndergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs) | Other | Screening (hepatitis B screening) |
| Survey AdministrationAncillary studies | Other | Screening (hepatitis B screening) |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- The University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica P Hwang principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Hepatitis B, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline blood tests, approximately 30 minutes for blood draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.