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Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer (CRICERVA)

This study is currently recruiting participants.
Verified June 2011 by Jordi Gol i Gurina Foundation
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01373723
First received: June 10, 2011
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  Purpose

The aim of this study was to compare the effectiveness and the costs of three types of population interventions to increase the number of female participants in the screening programmes for cancer of the cervix carried out by Primary Care in four Basic Health Care Areas.


Condition Intervention
Uterine Cervical Neoplasms
 Other: Different alternatives to improve the coverage of the populational screening programmes of cervical cancer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Economic Evaluation of Three Populational Screening Strategies for Cervical Cancer in the County of Valles Occidental: CRICERVA Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Clinical effectiveness measures [ Time Frame: Third year ] [ Designated as safety issue: No ]
    The main effectiveness measures of this evaluation would be the total number of cytologies performed, HPV infections detected, lesions of different grades detected, episodes of cancer detected and the number of deaths avoided

  • Costs measures [ Time Frame: Third year ] [ Designated as safety issue: No ]

    Include costs of diagnosis, interventions and treatment for all women

    • Diagnosis: cost of cytology, HPV determination test and control visit by the midwife or gynaecologist
    • Interventions: cost of a full-time administrator, personalized screening invitation letters, informative leaflets and phone calls
    • Treatment: will depend on the state of health of the women but may include the costs of the visits to the gynaecologist, cytology tests, HPV determination, control visits with the physician, costs of radical hysterectomy, radiotherapy, chemotherapy, etc


Estimated Enrollment: 20994
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: invitation letter
to participate in the screening
 Other: Different alternatives to improve the coverage of the populational screening programmes of cervical cancer
Cost-effectiveness analysis of 3 strategies to increase the recruitment of population screening for cervical cancer. These interventions will be compared to the current opportunistic screening strategy
Other Name: Cricerva
Experimental: Invitation letter, informative leaflet and phone call reminder
to participate in the screening
 Other: Different alternatives to improve the coverage of the populational screening programmes of cervical cancer
Cost-effectiveness analysis of 3 strategies to increase the recruitment of population screening for cervical cancer. These interventions will be compared to the current opportunistic screening strategy
Other Name: Cricerva
Experimental: Invitation letter and informative leaflet
to participate in the screening
 Other: Different alternatives to improve the coverage of the populational screening programmes of cervical cancer
Cost-effectiveness analysis of 3 strategies to increase the recruitment of population screening for cervical cancer. These interventions will be compared to the current opportunistic screening strategy
Other Name: Cricerva

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

20,994 women from 30 to 70 years of age with incorrect screening criteria (data obtained from Electronic Medical Records) ascribed to the Basic Health Care Area will be included in the study. Incorrect screening will be defined as [9]:

  1. - No cytology in the last 3 years from women between 30 to 40 years,
  2. - No cytology in the previous 5 years from women between 40 to 65 years,
  3. - No previous cytology history for females older than 65 years or women who have not had their last cytology before the age of 60

Exclusion Criteria:

  • hysterectomised women, with a current history of pre-malignant lesions (Atypical glandular cells of undetermined significance, Atypical squamous cells of undetermined significance, Low grade Squamous Intraepithelial Lesion, High grade Squamous Intraepithelial Lesion), carcinoma in situ and cervical-uterine cancer, HIV positive or other causes of immunosuppression (since these women follow a specific protocol);
  • those residing outside the study setting for more than 6 months;
  • those ascribed to the study Basic Health Care Area but with a physician assigned in an UBA (General Practicioner and Nurse Team) of another zone different from the one considered in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373723

Contacts
Contact: JM Manresa, Doctor jmanresa@idiapjgol.info
Contact: Amelia Acera, Doctor aacera.mn.ics@gencat.cat

Locations
Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain
Contact: JM Manresa, BS MSc         jmanresa@idiapjgol.info    
Contact: Pere Toran, MD         ptoran.bnm.ics@gencat.cat    
Principal Investigator: Amelia Acera, MD MSc            
Sub-Investigator: Ana Rodriguez, Midwife            
Sub-Investigator: Marta Trapero            
Sub-Investigator: Pilar Soteras            
Sub-Investigator: Norman Sanchez            
Sub-Investigator: JM Bonet            
Sub-Investigator: JM Manresa, BS MSc            
Sub-Investigator: Pablo Hidalgo            
Sub-Investigator: Pere Toran            
Sub-Investigator: Gemma Prieto            
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Amelia Acera, Doctor Institut Català de la Salut (ICS)
  More Information

No publications provided by Jordi Gol i Gurina Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amelia Acera Perez, Institut Català de la Salut (ICS)
ClinicalTrials.gov Identifier: NCT01373723     History of Changes
Other Study ID Numbers: PI10/01275
Study First Received: June 10, 2011
Last Updated: June 14, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Uterine Cervical Neoplasms
cancer screening
Costs and Cost Analysis
 cost-effectiveness analysis
Clinical Trial
Primary Health Care

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013