N/A
N=3,051
S1204, Viral Screening in Newly Diagnosed Cancer Patients
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01946516 ↗Enrolled (actual)
3,051
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Participants With Positive Viral Infection — 19; 197; 71; 34 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive Viral Infection |
19; 197; 71; 34; 11; 25 | — |
| SECONDARY Presence of Important Risk Factors in Participants Tested for Previous HBV |
14; 25; 176; 2725; 41; 135 | — |
| SECONDARY Presence of Important Risk Factors in Participants Tested for Chronic HBV |
8; 298; 10; 2624; 3; 145 | — |
| SECONDARY Presence of Important Risk Factors in Participants Tested for HCV |
21; 67; 48; 2746; 9; 45 | — |
| SECONDARY Presence of Important Risk Factors in Participants Tested for HIV |
16; 23; 18; 2877; 16; 101 | — |
| SECONDARY Type of Treatment for Cancer and Virus in Participants With Positive Viral Test |
11.8; 73.3; 8.2; 66.7; 19.6; 59.2 | — |
| SECONDARY Type and Rate of Adverse Events Among Patients With Viral Infection. |
— | — |
| SECONDARY Cost-effectiveness of Viral Screening |
— | — |
Summary
The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C infection among newly diagnosed cancer patients presenting to community and academic oncology clinics.
Eligibility Criteria
Inclusion Criteria
- presenting for evaluation or treatment of a new cancer malignancy(including hematologic)
- confirmed pathologic diagnosis must be within 120 days of registration (Patients presenting for "second opinions" of confirmed malignancies are eligible, including those who have started cancer treatment at other facilities)
- at least 18 years of age
- patient must have had their blood drawn for HIV, HBV and HCV testing prior to registration (Patients who have had HIV, HBV and/or HCV testing within 60 days prior to registration and who do not wish to be retested are eligible, provided supporting documents can be obtained confirming viral test results for all three viruses. Documentation must be obtained prior to registration.
Patients who are viral positive for either HIV, HBV, and/or HCV and who do not wish to be retested are eligible, provided documentation of viral load within 120 days prior to registration can be obtained. Note that these patients must be tested for or provide current viral load for all three viruses to be eligible. Documentation must be obtained prior to registration.)
- Patients must sign and give written informed consent in accordance with institutional and federal guidelines
- Patients must be offered the opportunity to allow their blood specimens to be banked by the SWOG Repository for future research
Exclusion Criteria
- diagnosed with a malignancy other than the current malignancy within the past five years (with the exception of basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ breast cancer.)
Data sourced from ClinicalTrials.gov (NCT01946516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.