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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

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