Uterine Cervical NeoplasmsEVITA LATAMNCT04947605
Epidemiological Landscape of Cervical Cancer in Latin America
An observational study of Uterine Cervical Neoplasms, run by Latin American Cooperative Oncology Group at 12 sites in 4 countries.
Trial summary
A portrait of clinical and epidemiological aspects of cervical cancer in Latin America is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 524 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 4 Nov 2021to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Data from approximately 482 patients are planned to be collected in 7 (seven) countries in Latin America. Enrollment period for data collection is planned to be 18 months and follow-up data will be recorded for 5 years. Patients will receive treatment and clinical assessments for cervical cancer as determined by their treating physician, according to the standard of care and routine clinical practice at each site.
Who may be able to join
- Women > 18 years.
- Histologically proven cervical carcinoma
- Diagnosis of carcinoma of the cervix since January 2018 or newly diagnosis or recurrent disease during the period of study recruitment.
- Any histology of cervical cancer at time of diagnosis.
- FIGO stage IB2-IVA
- Have available and adequate medical records for data collection
- Accept to participate in the project and sign the informed consent (if applicable)
Who cannot join
- FIGO stage I and IB1
- Non-invasive cervical cancer
- Synchronous tumor or second primary tumor in the last five years (exception for thyroid cancer or skin cancer non melanoma)
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Brazil8 sites
Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60335-480
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro, 20230-130
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Pérola Centro de Pesquisa em Oncologia
São Paulo, São Paulo, 01317-904
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01323-001
Argentina2 sites
Sanatorio de La Mujer
Rosario, Santa Fe Province
Centro Medico San Roque Exelsus
San Miguel de Tucumán, Tucumán Province
Dominican Republic1 site
INCART - Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares
Santo Domingo, Grande Santo Domingo
About this study
Official title: Epidemiological Landscape of Cervical Cancer in Latin America .
A portrait of clinical and epidemiological aspects of cervical cancer in Latin America is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. A better understanding of the current situation of this scenario will provide a valuable groundwork for the development of national and cooperative programs to improve cervical cancer prevention and treatment.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical Neoplasms
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
- Summarize the histologic subtype
Summarize the histologic subtype, assessed by the anatomopathological assay of the tumor sample and the stage at diagnosis, assessed by FIGO stage (International Federation of Gynecology and Obstetrics (FIGO) staging of cancer of the cervix uteri - 2018), using gynecological exam. Image studies and TNM stage (AJCC 8th edition) will also be used to assess stage at diagnosis when available.
Measured: January of 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start4 Nov 2021
- Primary completion31 Mar 2023
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 524 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Graziela Zibetti Dal Molin, MD, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947605
- Sponsor's protocol ID
- LACOG 0820
- Acronym
- EVITA LATAM
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Renna Junior NL, Silva GAE. Temporal trend and associated factors to advanced stage at diagnosis of cervical cancer: analysis of data from hospital based cancer registries in Brazil, 2000-2012. Epidemiol Serv Saude. 2018;27(2):e2017285. doi: 10.5123/s1679-49742018000200003. Epub 2018 May 7. English, Portuguese.
PubMed 29742234Nogueira-Rodrigues A. HPV Vaccination in Latin America: Global Challenges and Feasible Solutions. Am Soc Clin Oncol Educ Book. 2019 Jan;39:e45-e52. doi: 10.1200/EDBK_249695. Epub 2019 May 17.
PubMed 31099692Soneji S, Fukui N. Socioeconomic determinants of cervical cancer screening in Latin America. Rev Panam Salud Publica. 2013 Mar;33(3):174-82. doi: 10.1590/s1020-49892013000300003.
PubMed 23698136Lou H, Villagran G, Boland JF, Im KM, Polo S, Zhou W, Odey U, Juarez-Torres E, Medina-Martinez I, Roman-Basaure E, Mitchell J, Roberson D, Sawitzke J, Garland L, Rodriguez-Herrera M, Wells D, Troyer J, Pinto FC, Bass S, Zhang X, Castillo M, Gold B, Morales H, Yeager M, Berumen J, Alvirez E, Gharzouzi E, Dean M. Genome Analysis of Latin American Cervical Cancer: Frequent Activation of the PIK3CA Pathway. Clin Cancer Res. 2015 Dec 1;21(23):5360-70. doi: 10.1158/1078-0432.CCR-14-1837. Epub 2015 Jun 16.
PubMed 26080840Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
PubMed 30943124Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
PubMed 24552320Cancer Genome Atlas Research Network; Albert Einstein College of Medicine; Analytical Biological Services; Barretos Cancer Hospital; Baylor College of Medicine; Beckman Research Institute of City of Hope; Buck Institute for Research on Aging; Canada's Michael Smith Genome Sciences Centre; Harvard Medical School; Helen F. Graham Cancer Center &Research Institute at Christiana Care Health Services; HudsonAlpha Institute for Biotechnology; ILSbio, LLC; Indiana University School of Medicine; Institute of Human Virology; Institute for Systems Biology; International Genomics Consortium; Leidos Biomedical; Massachusetts General Hospital; McDonnell Genome Institute at Washington University; Medical College of Wisconsin; Medical University of South Carolina; Memorial Sloan Kettering Cancer Center; Montefiore Medical Center; NantOmics; National Cancer Institute; National Hospital, Abuja, Nigeria; National Human Genome Research Institute; National Institute of Environmental Health Sciences; National Institute on Deafness &Other Communication Disorders; Ontario Tumour Bank, London Health Sciences Centre; Ontario Tumour Bank, Ontario Institute for Cancer Research; Ontario Tumour Bank, The Ottawa Hospital; Oregon Health &Science University; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center; SRA International; St Joseph's Candler Health System; Eli &Edythe L. Broad Institute of Massachusetts Institute of Technology &Harvard University; Research Institute at Nationwide Children's Hospital; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; University of Bergen; University of Texas MD Anderson Cancer Center; University of Abuja Teaching Hospital; University of Alabama at Birmingham; University of California, Irvine; University of California Santa Cruz; University of Kansas Medical Center; University of Lausanne; University of New Mexico Health Sciences Center; University of North Carolina at Chapel Hill; University of Oklahoma Health Sciences Center; University of Pittsburgh; University of Sao Paulo, Ribeir ao Preto Medical School; University of Southern California; University of Washington; University of Wisconsin School of Medicine &Public Health; Van Andel Research Institute; Washington University in St Louis. Integrated genomic and molecular characterization of cervical cancer. Nature. 2017 Mar 16;543(7645):378-384. doi: 10.1038/nature21386. Epub 2017 Jan 23.
PubMed 28112728
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Landscape of Cervical Cancer in Latin America .
- ClinicalTrials.gov ID
- NCT04947605
- Acronym / sponsor ID
- EVITA LATAM / LACOG 0820
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jul 2021 (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.
A portrait of clinical and epidemiological aspects of cervical cancer in Latin America is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. A better understanding of the current situation of this scenario will provide a valuable groundwork for the development of national and cooperative programs to improve cervical cancer prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from approximately 482 patients are planned to be collected in 7 (seven) countries in Latin America. Enrollment period for data collection is planned to be 18 months and follow-up data will be recorded for 5 years. Patients will receive treatment and clinical assessments for cervical cancer as determined by their treating physician, according to the standard of care and routine clinical practice at each site.
Key inclusion criteria (7 listed)
- Women > 18 years.
- Histologically proven cervical carcinoma
- Diagnosis of carcinoma of the cervix since January 2018 or newly diagnosis or recurrent disease during the period of study recruitment.
- Any histology of cervical cancer at time of diagnosis.
- FIGO stage IB2-IVA
Key exclusion criteria (3 listed)
- FIGO stage I and IB1
- Non-invasive cervical cancer
- Synchronous tumor or second primary tumor in the last five years (exception for thyroid cancer or skin cancer non melanoma)
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
- Summarize the histologic subtype
Time frame: January of 2028
Summarize the histologic subtype, assessed by the anatomopathological assay of the tumor sample and the stage at diagnosis, assessed by FIGO stage (International Federation of Gynecology and Obstetrics (FIGO) staging of cancer of the cervix uteri - 2018), using gynecological exam. Image studies and TNM stage (AJCC 8th edition) will also be used to assess stage at diagnosis when available.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 29742234Renna Junior NL, Silva GAE. Temporal trend and associated factors to advanced stage at diagnosis of cervical cancer: analysis of data from hospital based cancer registries in Brazil, 2000-2012. Epidemiol Serv Saude. 2018;27(2):e2017285. doi: 10.5123/s1679-49742018000200003. Epub 2018 May 7. English, Portuguese.
- Background: PubMed 31099692Nogueira-Rodrigues A. HPV Vaccination in Latin America: Global Challenges and Feasible Solutions. Am Soc Clin Oncol Educ Book. 2019 Jan;39:e45-e52. doi: 10.1200/EDBK_249695. Epub 2019 May 17.
- Background: PubMed 23698136Soneji S, Fukui N. Socioeconomic determinants of cervical cancer screening in Latin America. Rev Panam Salud Publica. 2013 Mar;33(3):174-82. doi: 10.1590/s1020-49892013000300003.
- Background: PubMed 26080840Lou H, Villagran G, Boland JF, Im KM, Polo S, Zhou W, Odey U, Juarez-Torres E, Medina-Martinez I, Roman-Basaure E, Mitchell J, Roberson D, Sawitzke J, Garland L, Rodriguez-Herrera M, Wells D, Troyer J, Pinto FC, Bass S, Zhang X, Castillo M, Gold B, Morales H, Yeager M, Berumen J, Alvirez E, Gharzouzi E, Dean M. Genome Analysis of Latin American Cervical Cancer: Frequent Activation of the PIK3CA Pathway. Clin Cancer Res. 2015 Dec 1;21(23):5360-70. doi: 10.1158/1078-0432.CCR-14-1837. Epub 2015 Jun 16.
- Background: PubMed 30943124Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
- Background: PubMed 24552320Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. doi: 10.1056/NEJMoa1309748.
- Background: PubMed 28112728Cancer Genome Atlas Research Network; Albert Einstein College of Medicine; Analytical Biological Services; Barretos Cancer Hospital; Baylor College of Medicine; Beckman Research Institute of City of Hope; Buck Institute for Research on Aging; Canada's Michael Smith Genome Sciences Centre; Harvard Medical School; Helen F. Graham Cancer Center &Research Institute at Christiana Care Health Services; HudsonAlpha Institute for Biotechnology; ILSbio, LLC; Indiana University School of Medicine; Institute of Human Virology; Institute for Systems Biology; International Genomics Consortium; Leidos Biomedical; Massachusetts General Hospital; McDonnell Genome Institute at Washington University; Medical College of Wisconsin; Medical University of South Carolina; Memorial Sloan Kettering Cancer Center; Montefiore Medical Center; NantOmics; National Cancer Institute; National Hospital, Abuja, Nigeria; National Human Genome Research Institute; National Institute of Environmental Health Sciences; National Institute on Deafness &Other Communication Disorders; Ontario Tumour Bank, London Health Sciences Centre; Ontario Tumour Bank, Ontario Institute for Cancer Research; Ontario Tumour Bank, The Ottawa Hospital; Oregon Health &Science University; Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center; SRA International; St Joseph's Candler Health System; Eli &Edythe L. Broad Institute of Massachusetts Institute of Technology &Harvard University; Research Institute at Nationwide Children's Hospital; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University; University of Bergen; University of Texas MD Anderson Cancer Center; University of Abuja Teaching Hospital; University of Alabama at Birmingham; University of California, Irvine; University of California Santa Cruz; University of Kansas Medical Center; University of Lausanne; University of New Mexico Health Sciences Center; University of North Carolina at Chapel Hill; University of Oklahoma Health Sciences Center; University of Pittsburgh; University of Sao Paulo, Ribeir ao Preto Medical School; University of Southern California; University of Washington; University of Wisconsin School of Medicine &Public Health; Van Andel Research Institute; Washington University in St Louis. Integrated genomic and molecular characterization of cervical cancer. Nature. 2017 Mar 16;543(7645):378-384. doi: 10.1038/nature21386. Epub 2017 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Graziela Zibetti Dal Molin, MD principal investigator
Latin American Cooperative Oncology Group
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by Latin American Cooperative Oncology Group at 12 sites in 4 countries.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil, Argentina, Dominican Republic, Peru. 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?
This study is still under way. Results are not available in the source record yet.
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?
- Summarize the histologic subtype (time frame: January of 2028). 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 NCT04947605, which also lists 8 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 27 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.