Trial Title:
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
NCT ID:
NCT05510908
Condition:
HIV-Associated Malignant Neoplasm
HIV Infections
Cancer
AIDS Related Lymphoma
AIDS-related Kaposi Sarcoma
AIDS-Related Malignancy
Anal Cancer
HPV-Related Malignancy
Conditions: Official terms:
Sarcoma, Kaposi
Neoplasms
Sarcoma
Anus Neoplasms
Lymphoma, AIDS-Related
Conditions: Keywords:
HIV-Related Cancer
AIDS
AIDS-related malignancy
anal cancer
lymphoma
kaposi sarcoma
cervical cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional
Description:
Participants will be identified via screening of electronic medical records or
institutional databases. All eligible participants will have one visit for the collection
of broad demographic and clinical data. Data collection at study visit will occur via
survey procedures and/or medical record review.
Arm group label:
Metastic or locally advanced cancer
Arm group label:
New, primary or recurrent disease
Arm group label:
Prior cancer
Intervention type:
Other
Intervention name:
Non-Interventional Follow-up
Description:
Participants initiating or receiving ongoing treatment for their cancer will attend a
single follow-up visit to recollect broad demographic and clinical data. Data collection
at study visits will occur via survey procedures and/or medical record review.
Arm group label:
Metastic or locally advanced cancer
Arm group label:
New, primary or recurrent disease
Summary:
This study is being done to understand how many people with HIV (PWH) present for cancer
care across the AIDS Malignancy Consortium in the United States and if there are reasons
that some PWH choose to participate, or not in cancer clinical trials. Optional quality
of life surveys will be used to learn more about how HIV and cancer and HIV and cancer
treatment affect people.
Criteria for eligibility:
Study pop:
Participants with a dual diagnosis of both cancer (current or diagnosed within 5 years)
and underlying HIV infection, who present for care at AMC domestic sites.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Participant can understand and is willing to sign a written informed consent
document.
- HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- Documentation of an HIV diagnosis in the medical record by a licensed health
care provider;
- Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two
different medications that do not constitute a prescription for pre-exposure
prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a
record of an ART prescription in the medical record, a written prescription in
the name of the participant for ART, or pill bottles for ART with a label
showing the participant's name;
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA
copies/mL;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination
assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot
confirmation or HIV rapid multispot antibody differentiation assay.
Note: The term "licensed" refers to a kit that has been certified or licensed by an
oversight body within the participating country and validated internally (e.g., U.S.
FDA).
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention)
guidelines mandate that confirmation of the initial test result must use a test that is
different from the one used for the initial assessment. A reactive initial rapid test
should be confirmed by either another type of rapid assay, or an E/CIA that is based on a
different antigen preparation and/or different test principle (e.g., indirect versus
competitive), a Western blot, or a plasma HIV-1 RNA viral load.
- Patient was diagnosed with or treated for cancer within the last 5 years.
Participants will qualify under one of three categories:
- New, primary or recurrent diagnosis -Considering or currently receiving cancer
treatment
- Metastatic or locally advanced cancer - This includes cases for which there are
no current definitive therapy options for cure (i.e., inoperable) but may be
considered for non-standard / non-curative therapies.
- Prior diagnosis (within 5 years), in remission - Not currently on cancer
treatment other than ART or maintenance therapy.
- Age ≥ 18 years.
- Participant presents to an AMC domestic clinical trial site for either clinical care
or research.
Exclusion Criteria:
- Participants who do not fulfill the criteria as listed above are ineligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moores UCSD Cancer Center
Address:
City:
La Jolla
Zip:
92903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jayamalee De Silva, MD
Phone:
858-822-5377
Email:
jadesilva@health.ucsd.edu
Contact backup:
Last name:
Erin Reid, MD
Facility:
Name:
George Washington University Cancer Center
Address:
City:
District of columbia
Zip:
20037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Lush
Phone:
(202) 994-3647
Email:
mlush3@gwu.edu
Contact backup:
Last name:
Sharad Goyal, MD
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristina Bowles
Phone:
813-745-6239
Email:
Kristina.Bowles@moffitt.org
Contact backup:
Last name:
Anna Coghill, MD
Facility:
Name:
University of Illinois at Chicago
Address:
City:
Chicago
Zip:
60612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Shi
Phone:
312-996-9734
Email:
yshi@uic.edu
Contact backup:
Last name:
Paul Rubinstein, MD
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Clark
Phone:
410-502-5396
Email:
lclark53@jhmi.edu
Contact backup:
Last name:
Richard Ambinder, MD
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lee Ratner, MD, PhD
Phone:
314-362-8836
Email:
lratner@wustl.edu
Contact backup:
Last name:
Lee Ratner, MD, PhD
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jill Salvi
Email:
jsalvi@montefiore.org
Contact backup:
Last name:
Rafi Kabaritti, MD
Facility:
Name:
Weill Cornell Medicine - Cornell Clinical Trials Unit
Address:
City:
New York
Zip:
10010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grant Ellsworth, MD
Phone:
2127464177
Email:
gre9006@med.cornell.edu
Contact backup:
Last name:
Grant Ellsworth, MD
Facility:
Name:
Mount Sinai Hospital
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Keith Siegel, MD
Phone:
212-659-8551
Email:
keith.sigel@mssm.edu
Contact backup:
Last name:
Keith Siegel, MD
Facility:
Name:
The Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Brenner
Phone:
614-293-7843
Email:
Lisa.Brenner@osumc.edu
Contact backup:
Last name:
Gretchen McNally, APRN, CNP
Facility:
Name:
Abramson Cancer Center at Pennsylvania Hospital
Address:
City:
Philadelphia
Zip:
19106
Country:
United States
Status:
Recruiting
Contact:
Last name:
PAH Research Team
Phone:
215-829-7089
Email:
PAHemOncResearchTeam@PennMedicine.upenn.edu
Contact backup:
Last name:
Douglas Beach, MD
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Maggie Houchen
Phone:
713-563-3093
Email:
mehouchen@mdanderson.org
Contact backup:
Last name:
Elizabeth Chiao, MD, MPH
Facility:
Name:
Huntsman Cancer Institute - University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michelle Hess
Phone:
8016464357
Email:
michelle.hess@hci.utah.edu
Contact backup:
Last name:
Gita Suneja, MD
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marina Jovic
Phone:
206-287-6282
Email:
marina.jovic@vmfh.org
Contact backup:
Last name:
David Aboulafia, MD
Facility:
Name:
University of Puerto Rico
Address:
City:
San Juan
Zip:
00921
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Maribel Tirado-Gómez, MD
Phone:
787-772-8300
Phone ext:
1108
Email:
maribel.tirado1@upr.edu
Contact backup:
Last name:
Maribel Tirado-Gómez, MD
Start date:
July 25, 2023
Completion date:
September 2026
Lead sponsor:
Agency:
AIDS Malignancy Consortium
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
AIDS Malignancy Consortium
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05510908