HivNCT06774495
Cancer Prevalence and Outcomes in Individuals With HIV and AIDS: Multicenter BUHASDER Study
An observational study of Hiv and Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2024to 23 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Because it is a rare disease, the study will include all patients who have had HIV/AIDS and cancer in the last ten years.
Who may be able to join
- Patients over 18 years of age
- All patients with HIV seropositivity and concurrent pathology-confirmed cancer diagnosis
Who cannot join
- Pediatric patients
- Patients who do not attend follow-up visits and do not adhere to treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Prevalence and Outcomes in Individuals Living With HIV and AIDS: Multicenter BUHASDER Study
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.
Read the detailed description
Kaposi's sarcoma and B-cell lymphomas with an aggressive clinical course are observed in CD4+ T-cell lymphocytopenia and are with cervical cancer known as AIDS-defining cancers. According to data from the United States, the incidence of these cancers decreased by 70% in the 1990s after the discovery of the triple antiretroviral therapy. As survival increases, the proportion of non-AIDS-defining cancers also increases with advancing age. Cancer is now a leading cause of death in people living with HIV in developed countries, and cancer-related deaths are higher in people living with HIV. A study in Turkey reported HIV-associated non-Hodgkin's lymphoma cases, and a multicenter study reported 37 cancer cases between 1998 and 2016. However, HIV seroprevalence has been increasing in Turkey in recent years, and no studies have reflected the current cancer prevalence in individuals living with HIV and AIDS.
In our study, the investigators aimed to determine the prevalence and risk factors of cancer in individuals living with HIV and AIDS in Turkey over the last decade, and to show the age-related distribution and risk factors of HIV-related and unrelated cancer types.
As a secondary objective, the mortality rates and additional comorbid diseases that may affect mortality will be determined.
The current picture will be compared with data from the Turkish Statistical Institute in terms of cancer prevalence, type, and mortality.
It was planned to share the Excel file prepared by the principal investigator containing the data to be collected via e-mail and to evaluate all the data after collection via e-mail.
Statistical evaluation will be performed using IBM SPSS (version 29.0; IBM Corp., Armonk, NY, USA). Chi-square and Fisher's exact test will be used to compare the categorical variables. The conformity of measurement variables to a normal distribution will be examined using the Kolmogorov-Smirnov test. Descriptive analyses will be presented using the mean, standard deviation, median, and minimum-maximum values. Risk factors for cancer will be evaluated using the Mann-Whitney U test or Student's t-test. Cancer will be considered as the dependent variable and analyzed using univariate logistic regression with other variables. p value <0.05 will be considered significant. In a stepwise approach, the variables found to be significant in the univariate logistic regression test will be analyzed using multivariate logistic regression analysis. Cox regression will be used to analyze the factors affecting mortality and will be expressed in terms of the "hazard ratio".
- Keywords
- HIV, Acquired Immunodeficiency Syndrome, Cancer
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV&Malignancy | All AIDS-defining and non-defining cancers in individuals living with HIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Description: As a secondary objective, this outcome measure aims to determine mortality rates and additional comorbid diseases that may affect mortality in individuals living with HIV and AIDS.
Measurement Tool/Method: Mortality rates will be assessed through retrospective analysis of clinical outcomes and survival data.
Unit of Measure: Percentage of deceased individuals within the study population.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start12 Nov 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Principal investigator, Özlem Güler, Kocaeli University
- Investigators
- Özlem Güler, Assist Prof., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774495
- Sponsor's protocol ID
- GOKAEK-2024/04.06 2024-38
- Status last verified
- Apr 2025
- First submitted
- 4 Dec 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data may be shared with infectious disease physicians and academics for a period of two years following the release of the study protocol.
Publications
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.
PubMed 29539283Coghill 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.
PubMed 31050361Somay 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.
PubMed 33884350Aydin 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.
PubMed 32281636Guler O, Akhan S, Cagatay A, Batirel A, Sargin Altunok E, Bolukcu S, Ozkan Ozdemir H, Duman EI, Toygar Deniz M, Ozyigitoglu D, Ozden K, Alay H, Seyman D, Turken M, Calik S, Caydasi O, Ozturk Engin D, Gunal O, Topal S, Karabay O, Sarigul F, Karakoc Parlayan HN, Kilinc Toker A, Aydin O, Bayhan E, Ergen P, Ince N, Kaya S, Arslan Ozel S, Ozsahin A, Gurbuz E, Sahin A, Balci S, Kose S. Cancer prevalence and prognosis among individuals living with HIV and AIDS in Turkey: Multicenter BUHASDER study. Int J STD AIDS. 2026 Apr;37(5):500-510. doi: 10.1177/09564624251405965. Epub 2025 Dec 7.
PubMed 41353610
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevalence and Outcomes in Individuals Living With HIV and AIDS: Multicenter BUHASDER Study
- ClinicalTrials.gov ID
- NCT06774495
- Acronym / sponsor ID
- GOKAEK-2024/04.06 2024-38
- Keywords
- HIV, Acquired Immunodeficiency Syndrome, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Kaposi's sarcoma and B-cell lymphomas with an aggressive clinical course are observed in CD4+ T-cell lymphocytopenia and are with cervical cancer known as AIDS-defining cancers. According to data from the United States, the incidence of these cancers decreased by 70% in the 1990s after the discovery of the triple antiretroviral therapy. As survival increases, the proportion of non-AIDS-defining cancers also increases with advancing age. Cancer is now a leading cause of death in people living with HIV in developed countries, and cancer-related deaths are higher in people living with HIV. A study in Turkey reported HIV-associated non-Hodgkin's lymphoma cases, and a multicenter study reported 37 cancer cases between 1998 and 2016. However, HIV seroprevalence has been increasing in Turkey in recent years, and no studies have reflected the current cancer prevalence in individuals living with HIV and AIDS.
In our study, the investigators aimed to determine the prevalence and risk factors of cancer in individuals living with HIV and AIDS in Turkey over the last decade, and to show the age-related distribution and risk factors of HIV-related and unrelated cancer types.
As a secondary objective, the mortality rates and additional comorbid diseases that may affect mortality will be determined.
The current picture will be compared with data from the Turkish Statistical Institute in terms of cancer prevalence, type, and mortality.
It was planned to share the Excel file prepared by the principal investigator containing the data to be collected via e-mail and to evaluate all the data after collection via e-mail.
Statistical evaluation will be performed using IBM SPSS (version 29.0; IBM Corp., Armonk, NY, USA). Chi-square and Fisher's exact test will be used to compare the categorical variables. The conformity of measurement variables to a normal distribution will be examined using the Kolmogorov-Smirnov test. Descriptive analyses will be presented using the mean, standard deviation, median, and minimum-maximum values. Risk factors for cancer will be evaluated using the Mann-Whitney U test or Student's t-test. Cancer will be considered as the dependent variable and analyzed using univariate logistic regression with other variables. p value <0.05 will be considered significant. In a stepwise approach, the variables found to be significant in the univariate logistic regression test will be analyzed using multivariate logistic regression analysis. Cox regression will be used to analyze the factors affecting mortality and will be expressed in terms of the "hazard ratio".
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV&Malignancy | – | –All AIDS-defining and non-defining cancers in individuals living with HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- All patients with HIV seropositivity and concurrent pathology-confirmed cancer diagnosis
Key exclusion criteria (2 listed)
- Pediatric patients
- Patients who do not attend follow-up visits and do not adhere to treatment
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
Prevalence and risk factors of cancer in individuals living with HIV and AIDS
Time frame: 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.
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.
Risk Factors of Cancer in Individuals Living with HIV and AIDS
Time frame: 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.
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.
1 secondary outcome
Mortality Rate in Individuals Living with HIV and AIDS
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 29539283Yarchoan R, Uldrick TS. HIV-Associated Cancers and Related Diseases. N Engl J Med. 2018 Mar 15;378(11):1029-1041. doi: 10.1056/NEJMra1615896.
- Background: PubMed 31050361Coghill 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.
- Background: PubMed 33884350Somay 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.
- Background: PubMed 32281636Aydin 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.
- Derived from this study: PubMed 41353610Guler O, Akhan S, Cagatay A, Batirel A, Sargin Altunok E, Bolukcu S, Ozkan Ozdemir H, Duman EI, Toygar Deniz M, Ozyigitoglu D, Ozden K, Alay H, Seyman D, Turken M, Calik S, Caydasi O, Ozturk Engin D, Gunal O, Topal S, Karabay O, Sarigul F, Karakoc Parlayan HN, Kilinc Toker A, Aydin O, Bayhan E, Ergen P, Ince N, Kaya S, Arslan Ozel S, Ozsahin A, Gurbuz E, Sahin A, Balci S, Kose S. Cancer prevalence and prognosis among individuals living with HIV and AIDS in Turkey: Multicenter BUHASDER study. Int J STD AIDS. 2026 Apr;37(5):500-510. doi: 10.1177/09564624251405965. Epub 2025 Dec 7.
- Individual participant dataSharing planned: Yes. Data may be shared with infectious disease physicians and academics for a period of two years following the release of the study protocol.
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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.
Özlem Güler, Assist Prof. principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Cancer, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence and risk factors of cancer in individuals living with HIV and AIDS (time frame: 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.). The study lists 2 primary outcomes in all. 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 NCT06774495, which also lists 5 linked publications.
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 24 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.