CancerNCT01946516

S1204, Viral Screening in Newly Diagnosed Cancer Patients

An observational study of Cancer, run by SWOG Cancer Research Network at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
How many people: 3,051 participants
Where: 58 sitesUnited States
Study dates: 29 Aug 2013to 13 Oct 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Community and academic oncology clinics

Who may be able to join

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

Who cannot join

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.)

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

United States58 sites

The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Medical Oncology LLC
Baton Rouge, Louisiana, 70809
Mac Neal Hospital
Berwyn, Illinois, 60402
Billings Clinic Cancer Center
Billings, Montana, 59101
Boston Medical Center
Boston, Massachusetts, 02118
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Weiss Memorial Hospital
Chicago, Illinois, 60640
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215
Mary Bird Cancer Center/Saint Tammany Parish
Covington, Louisiana, 70433
Women's Cancer Care-Covington
Covington, Louisiana, 70433
Kaiser Permanente Hospital
Fontana, California, 92335
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650
Kaiser Permanente - Harbor City
Harbor City, California, 90710
Hines Veterans Administration Hospital
Hines, Illinois, 60141
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Mary Bird Perkins Cancer Center/Terrebonne General Medical Center
Houma, Louisiana, 70360
Oncology Center of The South Incorporated
Houma, Louisiana, 70360
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Veteran Administration Eastern Kansas Healthcare
Leavenworth, Kansas, 66048
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
OneHealth Marion General Hospital
Marion, Ohio, 43302
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642
East Jefferson General Hospital
Metairie, Louisiana, 70006
University Health-Conway
Monroe, Louisiana, 71202
Knox Community Hospital
Mount Vernon, Ohio, 43050
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Columbia University/Herbert Irving Cancer Center
New York, New York, 10032
Licking Memorial Hospital
Newark, Ohio, 43055
East Bay Physicians Medical Group-Summit
Oakland, California, 94609
Kaiser Permanente-Oakland
Oakland, California, 94611
Desert Regional Medical Center
Palm Springs, California, 92262
Kaiser Permanente - Panorama City
Panorama City, California, 91402
Kaiser Permanente Northwest
Portland, Oregon, 97227
Southern Ohio Medical Center
Portsmouth, Ohio, 45662
West Suburban Medical Center
River Forest, Illinois, 60305
Kaiser Permanente-Roseville
Roseville, California, 95661
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, 78209
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71103
North Shore Hematology Oncology Associates Inc
Slidell, Louisiana, 70458
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307
Topeka VA Hospital
Topeka, Kansas, 66622
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688

Other trials in United States

About this study

Official title: A Sero-Epidemiologic Survey and Cost Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients

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.

Read the detailed description

Primary Objective

Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus.

Secondary Objectives

Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer.
Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers.
Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection.
Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care.

Tertiary Objective

Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.

Conditions: Cancer
Keywords: viral screening
Medical subject headings: Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Positive Viral Infection
An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.
Measured: Up to 21 days after registration

Secondary outcomes (7)

Presence of Important Risk Factors in Participants Tested for Previous HBV
The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated.
Measured: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for Chronic HBV
The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated.
Measured: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for HCV
The presence or absence of specific risk factors among participants evaluated for HCV is evaluated.
Measured: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for HIV
The presence or absence of specific risk factors among participants evaluated for HIV is evaluated.
Measured: Up to 21 days after registration
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated.
Measured: 60 days after registration
Type and Rate of Adverse Events Among Patients With Viral Infection.
Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.
Measured: 5 years after registration
Cost-effectiveness of Viral Screening
Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.
Measured: 3 years after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 201313 Oct 2022

First posted19 Sep 2013 (estimated)
Study start29 Aug 2013
Primary completion1 Jan 2018
Study completion13 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by SWOG Cancer Research NetworkThe 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: Cohort
Time perspective: Prospective
Enrolment: 3,051 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01946516
Sponsor's protocol ID: S1204
Other IDs: NCI-2013-01631, U10CA032102
Status last verified: Jun 2023
First submitted: 16 Sep 2013
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sero-Epidemiologic Survey and Cost Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients
ClinicalTrials.gov ID: NCT01946516
Acronym / sponsor ID: S1204
Conditions: Cancer
Keywords: viral screening
Study type: Observational
Recruitment status: Completed
Enrolment: 3,051 participants (actual)
Lead sponsor: SWOG Cancer Research NetworkResearch network
Collaborators: National Cancer Institute (NCI)
Study start: 29 Aug 2013 (actual)
Primary completion: 1 Jan 2018 (actual)
Study completion: 13 Oct 2022 (actual)
First posted: 19 Sep 2013 (estimated)
Results: Posted 3 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Primary Objective

Secondary Objectives

Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer.
Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers.
Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection.
Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care.

Tertiary Objective

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community and academic oncology clinics

Key inclusion criteria (7 listed)

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.)

Key exclusion criteria (1 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Positive Viral Infection
Time frame: Up to 21 days after registration
An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.

7 secondary outcomes

Presence of Important Risk Factors in Participants Tested for Previous HBV
Time frame: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for Chronic HBV
Time frame: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for HCV
Time frame: Up to 21 days after registration
Presence of Important Risk Factors in Participants Tested for HIV
Time frame: Up to 21 days after registration
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Time frame: 60 days after registration
Type and Rate of Adverse Events Among Patients With Viral Infection.
Time frame: 5 years after registration
Cost-effectiveness of Viral Screening
Time frame: 3 years after registration

Results and safety

Results posted to the registry on 3 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HBV, HCV, or HIV Prevalence	3,051	3,051

Primary outcome: Number of Participants With Positive Viral Infection

Time frame: Up to 21 days after registration. Count of participants. Unit: Participants

Measure	Evaluated for Chronic HBV n = 3050	Evaluated for Previous HBV n = 3050	Evaluated for HCV n = 2990	Evaluated for HIV n = 3045
Positive Viral Test in All Participants	19	197	71	34
Positive Viral Test in Previously Diagnosed Participants	11	25	49	32
Positive Viral Test in Newly Diagnosed Participants	8	172	22	2
Positive Viral Test in Participants with Blood/Marrow Cancer	2	16	9	7
Positive Viral Test in Participants with Breast Cancer	4	66	9	2
Positive Viral Test in Participants with Colorectal Cancer	2	18	7	5
Positive Viral Test in Participants with Liver Cancer	4	5	9	0
Positive Viral Test in Participants with GI, Other Tract Cancer	3	22	3	5

Population analysed: The analysis population includes the 3051 participants eligible to receive at least one viral test (for HBV, HCV, or HIV). 3050 participants were evaluable for HBV analysis (1 participants had no HBV test results available), 2990 participants were evaluable for HCV analysis (5 participants had no HCV test results available and 56 participants incomplete test results), and 3045 participants were evaluable for HIV analysis (6 participants had no HIV test results available).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of study, 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HBV, HCV, or HIV Prevalence	0 of 3,051 (0%)	0 of 3,051 (0%)	0 of 3,051

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Active, not recruitingPhase 2
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Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
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RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
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Not yet recruitingPhase 1/2
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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.

Scott D. Ramsey, M.D. study chair

Fred Hutchinson Cancer Center

58 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by SWOG Cancer Research Network at 58 sites 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 7 inclusion and 1 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites 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?

Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Positive Viral Infection (time frame: Up to 21 days after registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01946516.

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 3 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.