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Cervix CancerNCT02671071

Prospective Evaluation of Patients With Uterine Cervical Cancer in Brazilian Health Institutions - The EVITA I Study

An observational study of Cervix Cancer, run by Latin American Cooperative Oncology Group at 16 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with CC in Brazil. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervix Cancer
What is being tested?
Quality of Life Questionnaire (QLQ)
How many people
638 participants
Where
16 sitesBrazil
Study dates
Apr 2016to Dec 2021
How long will I take part?
3 Years
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with cervical cancer in 1-year period (recently diagnosed IB to IIA high risk or IIB-IVB or recurrent disease - FIGO stages) at the participating sites will be included in the study.

Who may be able to join

  • Histologic confirmed invasive cervical cancer
  • Diagnosis of FIGO stages
  • Stage 1B to 2A high risk
  • 2B-4B or recurrent disease
  • Patients ≥18 years old

Who cannot join

  • Non-invasive uterine carcinoma;
  • Pregnancy;
  • synchronous tumor or second primary tumor in the past 5 years (except thyreoid ancer or non-melanoma skin cancer).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Brazil16 sites

  • UFMG

    Belo Horizonte, Minas Gerais

  • Hospital Geral de Roraima

    Boa Vista, Roraima

  • HU Walter Cantídeo

    Ceará, Fortaleza, CE

  • Hospital Erasto Gaertner

    Curitiba, Paraná

  • CEPON

    Florianópolis, Santa Catarina

  • CRIO

    Fortaleza, Ceará

  • Centro de Novos Tratamentos Litoral - Itajaí

    Itajaí, Santa Catarina

  • Fundação Centro de Controle do Câncer do Estado do Amazonas

    Manaus, Amazonas

  • Hospital São Vicente de Paulo

    Passo Fundo, Rio Grande do Sul

  • CPO - Hsl/Pucrs

    Porto Alegre, Rio Grande do Sul

  • IMIP

    Recife, Pernambuco

  • INCA

    Rio de Janeiro

  • Clínica AMO

    Salvador, Estado de Bahia

  • Hospital Alderona Bello

    São Luís, Maranhão

  • Hospital São José

    São Paulo

  • Instituto Brasileiro de Controle do Câncer - IBCC

    São Paulo

Other trials in Brazil

About this study

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with CC in Brazil.

Read the detailed description

The primary objective of this study is to describe the socio-demographic, clinical pathological, quality of life and treatment characteristics of patients diagnosed with cervix cancer (CC) in Brazil. Other specific objectives are:

  • To describe socio-demographic characteristics: age at diagnosis, education, family income, race, occupation, personal health habits - e.g.oral contraceptive use ever/never and duration; smoking never/ever/current/duration , ever drinking), sexual history, insurance coverage (private, public), institution (private, public, philanthropic), obstetric history, comorbidities, performance status, human papillomavirus vaccination or not
  • To describe the screening for CC: access, type, frequency and results.
  • To describe clinical pathological characteristics of CC: histology (adeno x squamous x adenosquamous x neuroendocrine x other) , International Federation of Gynecology and Obstetrics (FIGO) stage, pathological stage, exams for staging, date of diagnosis, site of metastasis.
  • To describe treatment characteristics of CC: date of surgery, type of surgery; date and duration of radiotherapy, type of radiotherapy; date, type and lines of systemic therapy (chemotherapy, monoclonal antibodies),
  • To describe treatment safety (grade 3-4 AEs, death due to treatment toxicity, discontinuation due to AE). In addition adverse events of special interest will be described (details on Safety section).
  • To describe the outcomes: follow-up exams and date of visits, persistent disease, recurrence, progression times in metastatic disease, complications (e.g. hydronephrosis/nephrostomy/ GI perforations and both GI \& genitourinary fistulae.), death due CC and death from any cause.
Conditions
Cervix Cancer
Being tested
Quality of Life Questionnaire (QLQ)
Keywords
Cervix Cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality of Life Questionnaire (QLQ)Behavioural

    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cervical cancer module (EORTC QLQ-CX24) will be applied to all patients at 0, 3, 6, 12, 24, 36 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of cervix cancer in the Brazilian female population

    Measured: 3 years

Secondary outcomes (13)

  1. Socio-demographic characteristics of the female population diagnosed with CC

    Measured: Month 0 (beginning of the study)

  2. Description of the method used to diagnose the brazillian female patients with cervix cancer

    Screening tests (Papanicolaou test) or symptoms presented by patients

    Measured: Month 0

  3. The clinical and pathological characteristics of cervix cancer in brazilian female patients

    Measured: Month 0

  4. Type of treatment assessed in patients with CC

    Radiotherapy, Chemotherapy and/or Surgery

    Measured: Month 0, 3, 6,12, 24 and 36

  5. Number of patients with disease survival

    Measured: Month 3, 6, 12, 24 and 36

  6. Number of patients with progression survival

    Measured: Month 3, 6, 12, 24 and 36

  7. Number of patients with overall survival

    Measured: Month 3, 6, 12, 24 and 36

  8. Number of patients with disease overall survival

    Measured: Month 3, 6, 12, 24 and 36

  9. Type and description of the indicated treatment after the diagnosis of cervix cancer in brazilian female patients

    Measured: Month 0, 3, 6,12, 24 and 36

  10. Duration of treatment after the diagnosis of cervix cancer

    Measured: Month 0, 3, 6,12, 24 and 36

  11. Description of adverse effects of the cervix cancer treatment

    Measured: Month 0, 3, 6,12, 24 and 36

  12. Number of adverse effects of the cervix cancer treatment

    Measured: Month 0, 3, 6,12, 24 and 36

  13. Type of clinical outcomes of the patients with cervix cancer in Brazil

    Measured: Month 0, 3, 6,12, 24 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2020
  4. Study completionDec 2021

Resources

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
Prospective
Enrolment
638 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02671071
Sponsor's protocol ID
LACOG 0215/EVA 001
Status last verified
Dec 2021
First submitted
15 Jan 2016
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Munoz N, Franco EL, Herrero R, Andrus JK, de Quadros C, Goldie SJ, Bosch FX. Recommendations for cervical cancer prevention in Latin America and the Caribbean. Vaccine. 2008 Aug 19;26 Suppl 11:L96-L107. doi: 10.1016/j.vaccine.2008.05.062.

    PubMed 18945407

  • Hellner K, Munger K. Human papillomaviruses as therapeutic targets in human cancer. J Clin Oncol. 2011 May 1;29(13):1785-94. doi: 10.1200/JCO.2010.28.2186. Epub 2011 Jan 10.

    PubMed 21220591

  • Martinez-Mesa J, Werutsky G, Campani RB, Wehrmeister FC, Barrios CH. Inequalities in Pap smear screening for cervical cancer in Brazil. Prev Med. 2013 Oct;57(4):366-71. doi: 10.1016/j.ypmed.2013.06.026. Epub 2013 Jul 1.

    PubMed 23827721

  • Zuliani AC, Esteves SC, Teixeira LC, Teixeira JC, de Souza GA, Sarian LO. Concomitant cisplatin plus radiotherapy and high-dose-rate brachytherapy versus radiotherapy alone for stage IIIB epidermoid cervical cancer: a randomized controlled trial. J Clin Oncol. 2014 Feb 20;32(6):542-7. doi: 10.1200/JCO.2013.50.1205. Epub 2014 Jan 21.

    PubMed 24449243

  • Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. doi: 10.1200/JCO.2002.20.4.966.

    PubMed 11844818

Questions about this trial

What is this clinical trial studying?

An observational study of Cervix Cancer, run by Latin American Cooperative Oncology Group at 16 sites in Brazil.

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 5 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: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Brazil. 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?

Characterization of cervix cancer in the Brazilian female population (time frame: 3 years). 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 NCT02671071, which also lists 6 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 Dec 2021.

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