Cancer Prevalence and Outcomes in Individuals With HIV and AIDS: Multicenter BUHASDER Study

NCT06774495 | Completed

• 1 other identifier: GOKAEK-2024/04.06 2024-38
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

AIDS-defining cancers reported a 70% drop in the 1990s following the advent of triple antiretroviral therapy in the USA. With increased survival, the proportion of non-AIDS-defining cancers increases with age, making cancer a leading cause of death among individuals with HIV infection in developed countries, with higher cancer-related mortality rates in this group. In Turkey, studies have reported HIV-associated non-Hodgkin lymphoma cases, and a multicentre study documented 37 cancer cases from 1998 to 2016. This study aims to determine the prevalence of cancer in individuals with HIV and AIDS in Turkey over the past decade, examining the age-related distribution and risk factors for HIV-related and unrelated cancers. Additionally, the mortality rates and comorbidities affecting mortality will be assessed. The findings will be compared with the Turkish Statistical Institute's data on cancer prevalence, type, and mortality.

Conditions

Hiv; Cancer

Keywords

HIV; Acquired Immunodeficiency Syndrome; Cancer

Outcome Measures

Primary Outcomes (2)

• Prevalence and risk factors of cancer in individuals living with HIV and AIDS

  This outcome measure aims to determine the prevalence of cancer in individuals living with HIV and AIDS in Turkey, including age-related distribution and cancer types. Measurement Tool/Method: Cancer prevalence will be assessed through retrospective analysis of patient records and registry data. Unit of Measure: Percentage of individuals diagnosed with cancer.

  Medical records of individuals living with HIV who were diagnosed with cancer between November 1, 2014, and November 1, 2024, will be reviewed starting on November 12, 2024. Patients will be enrolled in the study beginning on November 12, 2024.

• Risk Factors of Cancer in Individuals Living with HIV and AIDS

  This outcome measure aims to identify risk factors associated with cancer in individuals living with HIV and AIDS, including both HIV-related and unrelated cancer types. Measurement Tool/Method: Risk factors will be analyzed using multivariate regression models based on demographic, clinical, and treatment-related variables. Unit of Measure: Odds ratios (OR) for specific risk factors.

  Medical records of individuals living with HIV who were diagnosed with cancer between November 1, 2014, and November 1, 2024, will be reviewed starting on November 12, 2024. Patients will be enrolled in the study beginning on November 12, 2024.

Secondary Outcomes (1)

• Mortality Rate in Individuals Living with HIV and AIDS

  Medical records of individuals living with HIV who were diagnosed with cancer between November 1, 2014, and November 1, 2024, will be reviewed starting on November 12, 2024. Patients will be enrolled in the study beginning on November 12, 2024.

Study Arms (1)

HIV&Malignancy

All AIDS-defining and non-defining cancers in individuals living with HIV

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

Because it is a rare disease, the study will include all patients who have had HIV/AIDS and cancer in the last ten years.

You may qualify if:

• Patients over 18 years of age
• All patients with HIV seropositivity and concurrent pathology-confirmed cancer diagnosis

You may not qualify if:

• Pediatric patients
• Patients who do not attend follow-up visits and do not adhere to treatment

Sponsors & Collaborators

• Kocaeli University: lead
• Dokuz Eylul University: collaborator

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (4)

• Yarchoan R, Uldrick TS. HIV-Associated Cancers and Related Diseases. N Engl J Med. 2018 Mar 15;378(11):1029-1041. doi: 10.1056/NEJMra1615896.

  PMID: 29539283 BACKGROUND

• Coghill AE, Han X, Suneja G, Lin CC, Jemal A, Shiels MS. Advanced stage at diagnosis and elevated mortality among US patients with cancer infected with HIV in the National Cancer Data Base. Cancer. 2019 Aug 15;125(16):2868-2876. doi: 10.1002/cncr.32158. Epub 2019 May 3.

  PMID: 31050361 BACKGROUND

• Somay K, Copur S, Osmanbasoglu E, Masyan H, Arslan H, Akay OM, Tekin S, Ferhanoglu B. HIV-ASSOCIATED NON HODGKIN LYMPHOMA: A CASE SERIES STUDY FROM TURKEY. Afr J Infect Dis. 2020 Jul 31;14(2):42-47. doi: 10.21010/ajid.v14i2.7. eCollection 2020.

  PMID: 33884350 BACKGROUND

• Aydin OA, Gunduz A, Sargin F, Mete B, Karaosmanoglu HK, Sevgi DY, Yemisen M, Durdu B, Dokmetas I, Tabak F; ACTHIV-IST (Action Against HIV in Istanbul) Study Group. Prevalence and mortality of cancer among people living with HIV and AIDS patients: a large cohort study in Turkey. East Mediterr Health J. 2020 Mar 24;26(3):276-282. doi: 10.26719/emhj.19.030.

  PMID: 32281636 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Özlem Güler, Assist Prof.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: January 14, 2025
• Study Start: November 12, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data can be shared for two years after study protocol release.
• Access Criteria: Infectious disease physicians access is appropriate

Locations

TU (1)