S1204, Viral Screening in Newly Diagnosed Cancer Patients

NCT01946516 | Completed Results DMC

• 3 other identifiers: S1204NCI-2013-01631U10CA032102
• Study Type: observational
• Target: 3,051
• Locations: 1 country
• Sites: 58

Brief 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.

Conditions

Cancer

Keywords

viral screening

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 21 days after registration

Secondary Outcomes (7)

• Presence of Important Risk Factors in Participants Tested for Previous HBV

  Up to 21 days after registration

• Presence of Important Risk Factors in Participants Tested for Chronic HBV

  Up to 21 days after registration

• Presence of Important Risk Factors in Participants Tested for HCV

  Up to 21 days after registration

• Presence of Important Risk Factors in Participants Tested for HIV

  Up to 21 days after registration

• Type of Treatment for Cancer and Virus in Participants With Positive Viral Test

  60 days after registration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community and academic oncology clinics

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (58)

Kaiser Permanente Hospital

Fontana, California, 92335, United States

Location

Kaiser Permanente - Harbor City

Harbor City, California, 90710, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

East Bay Physicians Medical Group-Summit

Oakland, California, 94609, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, 80124, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Mac Neal Hospital

Berwyn, Illinois, 60402, United States

Location

Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Hines Veterans Administration Hospital

Hines, Illinois, 60141, United States

Location

West Suburban Medical Center

River Forest, Illinois, 60305, United States

Location

Veteran Administration Eastern Kansas Healthcare

Leavenworth, Kansas, 66048, United States

Location

Topeka VA Hospital

Topeka, Kansas, 66622, United States

Location

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, 70805, United States

Location

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Medical Oncology LLC

Baton Rouge, Louisiana, 70809, United States

Location

Mary Bird Cancer Center/Saint Tammany Parish

Covington, Louisiana, 70433, United States

Location

Women's Cancer Care-Covington

Covington, Louisiana, 70433, United States

Location

Mary Bird Perkins Cancer Center/Terrebonne General Medical Center

Houma, Louisiana, 70360, United States

Location

Oncology Center of The South Incorporated

Houma, Louisiana, 70360, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

University Health-Conway

Monroe, Louisiana, 71202, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71103, United States

Location

North Shore Hematology Oncology Associates Inc

Slidell, Louisiana, 70458, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Columbia University/Herbert Irving Cancer Center

New York, New York, 10032, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

OneHealth Marion General Hospital

Marion, Ohio, 43302, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026-1967, United States

Location

Audie L Murphy Veterans Affairs Hospital

San Antonio, Texas, 78209, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimen submission is optional.

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Cancer Care Delivery Committee Statistician
• Organization: SWOG Statistics and Data Management Center

karnold@fredhutch.org

2066674623

Study Officials

• Scott D. Ramsey, M.D.

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 19, 2013
• Study Start: August 29, 2013
• Primary Completion: January 1, 2018
• Study Completion: October 13, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Locations

US (58)