IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in HIV Patients

NCT04735445 | Unknown

• 1 other identifier: IMPACNEO
• Study Type: interventional
• Target: 4,638
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The incidence of malignancies is higher in the HIV-infected population than in the general population, and it is already one of the leading causes of death in people living with the virus. It is estimated that the situation will be aggravated by the progressive aging of the HIV-infected population. Early diagnosis through enhanced cancer screening can be critical in reducing mortality, but may increase expenditure and harms associated with adverse events. This strategy should then be considered only when the benefits clearly outweigh the harms. There are currently no studies on expanded cancer screening in patients with HIV, and available information from the point of view of costeffectiveness or cost-utility is scarce. Hypothesis: An enhanced program for non-aids cancer screening in patients with HIV can lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions and being cost-effective. Objectives: To evaluate the efficacy, safety and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Specific objectives: 1) To compare the incidence of early diagnosed cancer with enhanced screening versus conventional screening; 2) To assess the incidence of early diagnosed cancer and its overall incidence in the CoRIS cohort; 3) To analyze safety of the program: adverse events and unnecessary interventions; 4) To compare the obtained data stratifying by gender and 5) To analyze the cost-utility of the program. Expected results: 1) To generate scientific evidence to inform decision makers on the advisability of implementing an enhanced screening program of cancer in HIV-infected patients; 2) To broaden knowledge about the programs of early detection of cancer in vulnerable populations and their economic evaluation from the perspective of the National Health Service.

Conditions

HIV/AIDS; Cancer

Keywords

HIV; Neoplasm; Screening; Early diagnosis

Outcome Measures

Primary Outcomes (2)

• Non-AIDS defining cancers incidence

  The incidence of different neoplasms not considered as AIDS defining cancers compared between two arms

  through study completion, an average of 1 year

• Survival rate

  Comparison in survival terms between conventional and enhanced screening arms

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Safety of the screening: adverse events

  through study completion, an average of 1 year

• Cost-efectiveness

  through study completion, an average of 1 year

Study Arms (2)

Conventional screening

ACTIVE COMPARATOR

Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).

Diagnostic Test: Digital rectal exam and / or anal cytology (day 1 and after 36 months); Diagnostic Test: Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months); Diagnostic Test: Appointment for mammography (day 1 and after 36 months); Diagnostic Test: Semestral appointment for liver ultrasound; Diagnostic Test: Fecal occult blood test (day 1 and after 36 months); Diagnostic Test: Digital rectal exam and PSA determination (day 1 and after 36 months)

Enhanced screening

EXPERIMENTAL

Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.

Diagnostic Test: Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy; Diagnostic Test: Semestral cervical cytology and cervical sample for HPV detection; Diagnostic Test: Annual appointment for mammography; Diagnostic Test: Semestral appointment for liver ultrasound; Diagnostic Test: Semestral blood collection for alpha-fetoprotein and others hepatic biomarkers determination; Diagnostic Test: Annual fecal occult blood test; Diagnostic Test: Annual digital rectal exam and PSA determination; Diagnostic Test: Annual appointment for low dose computed tomography for lung screening; Diagnostic Test: Annual general inspection for skin lesions suggestive of malignancy

Interventions

Digital rectal exam and / or anal cytology (day 1 and after 36 months) DIAGNOSTIC_TEST

For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (day 1 and after 36 months)

Conventional screening

Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy DIAGNOSTIC_TEST

For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (semestral)

Enhanced screening

Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months) DIAGNOSTIC_TEST

For Cervix Screening in sexually active woman (day 1 and after 36 months)

Conventional screening

Semestral cervical cytology and cervical sample for HPV detection DIAGNOSTIC_TEST

For Cervix Screening in sexually active woman (semestral)

Enhanced screening

Appointment for mammography (day 1 and after 36 months) DIAGNOSTIC_TEST

For Breast Screening in woman between 50-70 years old (day 1 and after 36 months)

Conventional screening

Annual appointment for mammography DIAGNOSTIC_TEST

For Breast Screening in woman between 45-70 years old (annual)

Enhanced screening

Semestral appointment for liver ultrasound DIAGNOSTIC_TEST

For Hepatic Screening: Cirrhosis or Chronic HBV, and meet any of the following risk factors: * Asian male\> 40 years old * Asian woman\> 50 years old * African man or woman * HCC family history

Conventional screening

Semestral blood collection for alpha-fetoprotein and others hepatic biomarkers determination DIAGNOSTIC_TEST

Having chronic liver disease with fibrosis ≥ F3 or Presents chronic HBV

Enhanced screening

Fecal occult blood test (day 1 and after 36 months) DIAGNOSTIC_TEST

For Colon Screening: Age between 50-70 years old

Conventional screening

Annual fecal occult blood test DIAGNOSTIC_TEST

For Colon Screening: Age older than 40 years

Enhanced screening

Digital rectal exam and PSA determination (day 1 and after 36 months) DIAGNOSTIC_TEST

For Prostate Screening: Man older than 50 years

Conventional screening

Annual digital rectal exam and PSA determination DIAGNOSTIC_TEST

For Prostate Screening: Man older than 50 years

Enhanced screening

Annual appointment for low dose computed tomography for lung screening DIAGNOSTIC_TEST

For Lung Screening: should accomplish ALL the following criteria: * Age \> 40 years * Active smoker or former smoker\<3 years, with IPY ≥20. IPY: index of packages-year: nº packages that smoke per day x nº years smoking * No contraindications for thoracic surgery * No lung infection in the last 2 months

Enhanced screening

Annual general inspection for skin lesions suggestive of malignancy DIAGNOSTIC_TEST

For Skin Screening: Woman ≥18 years Man ≥40 years

Enhanced screening

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Both genders should be represented in a real incidence estimation of Spanish population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male ≥40 years or woman ≥18 years
• Informed Consent signed

You may not qualify if:

• Active AIDS defining disease
• Antecedent of cancer
• Terminal disease
• Pregnancy or breastfeeding
• Patient rejection

Sponsors & Collaborators

• Felix Gutierrez: lead
• Instituto de Salud Carlos III: collaborator
• Hospital General Universitario Reina Sofía de Murcia: collaborator
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital General Universitario Santa Lucia: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator
• Hospital Universitario de Guadalajara: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Hospital Universitario La Fe: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Complejo Hospitalario Universitario de Albacete: collaborator
• Hospital Universitario Fundación Alcorcón: collaborator
• Hospital General Universitario Elche: collaborator

Study Sites (1)

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (19)

• Lopez C, Masia M, Padilla S, Aquilino A, Bas C, Gutierrez F. [Deaths due to non-AIDS diseases among HIV infected patients: A 14-year study (1998-2011)]. Enferm Infecc Microbiol Clin. 2016 Apr;34(4):222-7. doi: 10.1016/j.eimc.2015.04.010. Epub 2015 Jun 18. Spanish.

  PMID: 26093959 RESULT

• Garcia-Abellan J, Del Rio L, Garcia JA, Padilla S, Vivancos MJ, Del Romero J, Asensi V, Hernando A, Garcia-Fraile L, Masia M, Gutierrez F; la Cohorte de la Red Nacional de Sida (CoRIS). Risk of cancer in HIV-infected patients in Spain, 2004-2015. The CoRIS cohort study. Enferm Infecc Microbiol Clin (Engl Ed). 2019 Oct;37(8):502-508. doi: 10.1016/j.eimc.2018.11.011. Epub 2019 Jan 22. English, Spanish.

  PMID: 30679001 RESULT

• Smith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8.

  PMID: 25042234 RESULT

• Shiels MS, Cole SR, Kirk GD, Poole C. A meta-analysis of the incidence of non-AIDS cancers in HIV-infected individuals. J Acquir Immune Defic Syndr. 2009 Dec;52(5):611-22. doi: 10.1097/QAI.0b013e3181b327ca.

  PMID: 19770804 RESULT

• Grulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007 Jul 7;370(9581):59-67. doi: 10.1016/S0140-6736(07)61050-2.

  PMID: 17617273 RESULT

• Althoff KN, McGinnis KA, Wyatt CM, Freiberg MS, Gilbert C, Oursler KK, Rimland D, Rodriguez-Barradas MC, Dubrow R, Park LS, Skanderson M, Shiels MS, Gange SJ, Gebo KA, Justice AC; Veterans Aging Cohort Study (VACS). Comparison of risk and age at diagnosis of myocardial infarction, end-stage renal disease, and non-AIDS-defining cancer in HIV-infected versus uninfected adults. Clin Infect Dis. 2015 Feb 15;60(4):627-38. doi: 10.1093/cid/ciu869. Epub 2014 Oct 30.

  PMID: 25362204 RESULT

• Cobucci RN, Lima PH, de Souza PC, Costa VV, Cornetta Mda C, Fernandes JV, Goncalves AK. Assessing the impact of HAART on the incidence of defining and non-defining AIDS cancers among patients with HIV/AIDS: a systematic review. J Infect Public Health. 2015 Jan-Feb;8(1):1-10. doi: 10.1016/j.jiph.2014.08.003. Epub 2014 Oct 5.

  PMID: 25294086 RESULT

• Masia M, Padilla S, Alvarez D, Lopez JC, Santos I, Soriano V, Hernandez-Quero J, Santos J, Tural C, del Amo J, Gutierrez F; CoRIS. Risk, predictors, and mortality associated with non-AIDS events in newly diagnosed HIV-infected patients: role of antiretroviral therapy. AIDS. 2013 Jan 14;27(2):181-9. doi: 10.1097/QAD.0b013e32835a1156.

  PMID: 23018442 RESULT

• Patel P, Hanson DL, Sullivan PS, Novak RM, Moorman AC, Tong TC, Holmberg SD, Brooks JT; Adult and Adolescent Spectrum of Disease Project and HIV Outpatient Study Investigators. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992-2003. Ann Intern Med. 2008 May 20;148(10):728-36. doi: 10.7326/0003-4819-148-10-200805200-00005.

  PMID: 18490686 RESULT

• Shiels MS, Engels EA. Evolving epidemiology of HIV-associated malignancies. Curr Opin HIV AIDS. 2017 Jan;12(1):6-11. doi: 10.1097/COH.0000000000000327.

  PMID: 27749369 RESULT

• Croxford S, Kitching A, Desai S, Kall M, Edelstein M, Skingsley A, Burns F, Copas A, Brown AE, Sullivan AK, Delpech V. Mortality and causes of death in people diagnosed with HIV in the era of highly active antiretroviral therapy compared with the general population: an analysis of a national observational cohort. Lancet Public Health. 2017 Jan;2(1):e35-e46. doi: 10.1016/S2468-2667(16)30020-2. Epub 2016 Dec 15.

  PMID: 29249478 RESULT

• Wang YH, Shen XD. Human immunodeficiency virus infection and mortality risk among lung cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Apr;97(15):e0361. doi: 10.1097/MD.0000000000010361.

  PMID: 29642182 RESULT

• Trickey A, May MT, Gill MJ, Grabar S, Vehreschild J, Wit FWNM, Bonnet F, Cavassini M, Abgrall S, Berenguer J, Wyen C, Reiss P, Grabmeier-Pfistershammer K, Guest JL, Shepherd L, Teira R, d'Arminio Monforte A, Del Amo J, Justice A, Costagliola D, Sterne JAC. Cause-specific mortality after diagnosis of cancer among HIV-positive patients: A collaborative analysis of cohort studies. Int J Cancer. 2020 Jun 1;146(11):3134-3146. doi: 10.1002/ijc.32895. Epub 2020 Mar 12.

  PMID: 32003460 RESULT

• Santos J, Valencia E; Panel de Expertos de GeSIDA. [Consensus statement on the clinical management of non-AIDS defining malignancies. GeSIDA expert panel]. Enferm Infecc Microbiol Clin. 2014 Oct;32(8):515-22. doi: 10.1016/j.eimc.2014.04.008. Epub 2014 Jun 20. Spanish.

  PMID: 24953385 RESULT

• GBD 2015 HIV Collaborators. Estimates of global, regional, and national incidence, prevalence, and mortality of HIV, 1980-2015: the Global Burden of Disease Study 2015. Lancet HIV. 2016 Aug;3(8):e361-e387. doi: 10.1016/S2352-3018(16)30087-X. Epub 2016 Jul 19.

  PMID: 27470028 RESULT

• Rubinstein PG, Aboulafia DM, Zloza A. Malignancies in HIV/AIDS: from epidemiology to therapeutic challenges. AIDS. 2014 Feb 20;28(4):453-65. doi: 10.1097/QAD.0000000000000071.

  PMID: 24401642 RESULT

• Ryom L, Cotter A, De Miguel R, Beguelin C, Podlekareva D, Arribas JR, Marzolini C, Mallon P, Rauch A, Kirk O, Molina JM, Guaraldi G, Winston A, Bhagani S, Cinque P, Kowalska JD, Collins S, Battegay M; EACS Governing Board. 2019 update of the European AIDS Clinical Society Guidelines for treatment of people living with HIV version 10.0. HIV Med. 2020 Nov;21(10):617-624. doi: 10.1111/hiv.12878. Epub 2020 Sep 3.

  PMID: 32885559 RESULT

• Gutierrez F, Lopez L, Galera C, Tiraboschi JM, Portu J, Garcia-Fraile L, Garcia Del Toro M, Bernal E, Rivero A, Garcia-Abellan J, Flores J, Gonzalez-Cordon A, Martinez O, Bravo J, Rosado D, Montero M, Sirera G, Torralba M, Galindo MJ, Macias J, Gonzalez-Cuello I, Boix V, Vivancos MJ, Dios P, Blanco JR, Padilla S, Fernandez-Gonzalez M, Gutierrez-Ortiz de la Tabla A, Martinez E, Masia M; IMPAC-Neo Study Group. Early Detection of Cancer and Precancerous Lesions in Persons With HIV Through a Comprehensive Cancer Screening Protocol. Clin Infect Dis. 2025 Feb 24;80(2):371-380. doi: 10.1093/cid/ciae359.

  PMID: 38959300 DERIVED

• Masia M, Padilla S, Estan G, Portu J, Silva A, Rivero A, Gonzalez-Cordon A, Garcia-Fraile L, Martinez O, Bernal E, Galera C, Boix Martinez V, Macias J, Montero M, Garcia-Rosado D, Vivancos-Gallego MJ, Llenas-Garcia J, Torralba M, Garcia JA, Agullo V, Fernandez-Gonzalez M, Gutierrez F, Martinez E; IMPAC-NEO Study Group. Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection. Trials. 2021 Nov 27;22(1):851. doi: 10.1186/s13063-021-05777-6.

  PMID: 34838115 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Neoplasms; Disease

Interventions

Biopsy; Mammography; Occult Blood; Tomography, X-Ray Computed

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Radiography; Diagnostic Imaging; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography

Study Officials

• Félix Gutiérrez-Rodero, PhD

  Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Padilla-Urrea, PhD

CONTACT

+34 966616234; padilla_ser@gva.es

Gabriel Estan-Cerezo, PhD

CONTACT

+34 966616234; estany_gab@gva.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: November 11, 2019
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

ES (1)