Trial Title:
Early Detection of Cancers in Low Resource Countries
NCT ID:
NCT01178736
Condition:
Breast Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Conditions: Keywords:
neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Breast Cancer Screening and Diagnosis
Description:
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy
(FNAB) of screen positive cases.
Arm group label:
Cancer Screening and Diagnosis
Other name:
FNAB
Other name:
CBE
Other name:
Ultrasound
Intervention type:
Procedure
Intervention name:
Cervical Cancer Screening and Diagnosis
Description:
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing
followed by Cryotherapy of screen positive cases.
Arm group label:
Cancer Screening and Diagnosis
Other name:
HPV DNA
Intervention type:
Procedure
Intervention name:
Ovarian Cancer Screening and Diagnosis
Description:
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms
suggestive of ovarian cancer.
Arm group label:
Cancer Screening and Diagnosis
Other name:
Ultrasound
Intervention type:
Procedure
Intervention name:
Endometrial Cancer Screening and Diagnosis
Description:
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women
with abnormal bleeding.
Arm group label:
Cancer Screening and Diagnosis
Other name:
Ultrasound
Summary:
The purpose of this study is to implement a community-based combined program for early
detection of breast, cervical, ovarian and endometrial cancer in low-resource countries
delivered through a free standing or a mobile Well Woman Clinic. The goals of this
program are to downstage cancers and improve mortality rates using low-cost early
detection methods. These programs will be implemented in regions where early cancer
detection strategies are not in place and cancers present at advanced stages with
resultant high mortality. Currently, there are three target project sites: Cambodia (June
2011), India (June 2011), and Brazil (March 2011). Memorandums of Understanding have been
secured with local health organizations in each region to establish clinic operations.
Each clinic would serve an approximate target population of 100,000 amongst whom about
12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and
cervical cancer over a three-year time span.
Detailed description:
We will study the use of sonographic screening in addition to Clinical Breast Examination
in low resource settings where screening programs are not currently in place and
establishing a population based mammographic screening would be expensive, resource
intensive, and difficult if not impossible to implement. The effectiveness of the
screening and diagnostic methodology used for early detection of breast, cervical,
ovarian and endometrial cancers in low resource settings will be studied. The program
would involve screening of asymptomatic women for Breast and Cervical cancer and
diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer. Women in
the age group of 30-59 yrs will be screened once every three years utilizing the
following methods: Breast - clinical breast examination [CBE] and Sonography, followed by
Fine needle aspiration biopsy (FNAB) of screen positive cases; Cervical - Human Papilloma
Virus DNA testing followed by Cryotherapy of screen positive cases (Single visit, screen
and treat approach); Ovarian - Transvaginal sonogram and clinical evaluation; Endometrial
- Transvaginal sonographic assessment of the endometrial stripe.
Criteria for eligibility:
Study pop:
Brazil has two rural hospitals serving a population of roughly 46,000 people (Nova
Andradina) inside Mato Grosso do Sul, which has a population of over 2 million. Cambodia
has a population of over 1 million inside the Phnom Penh metropolitan area. India has a
population of more than 1.3 million inside the state of Goa. According to the NFHS-2,
nearly 30 percent of rural Goan women live 10 or more kilometers away from a primary
health center.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Breast Cancer: women age 35-64
- Cervical Cancer: women age 30-59
- Ovarian Cancer: symptomatic post menopausal women age 50-64
- Endometrial Cancer: symptomatic post menopausal women age 50-64
Exclusion Criteria:
- women under the age of 30
Gender:
Female
Minimum age:
30 Years
Maximum age:
64 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital de Cancer de Barretos
Address:
City:
Sao Paolo
Country:
Brazil
Contact:
Last name:
Edmundo Mauad, MD, PhD
Phone:
(17) 3321-6600
Email:
ecmauad@hcancerbarretos.com.br
Investigator:
Last name:
Edmundo Mauad, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia
Address:
City:
Phnom Penh
Country:
Cambodia
Contact:
Last name:
Cornelia Haener, MD
Phone:
(855-23) 882-484
Email:
corneliahaener@sihosp.org
Contact backup:
Last name:
Shelly Malhotra
Email:
shellymalhotra@sihosp.org
Investigator:
Last name:
Cornelia Haener, MD
Email:
Principal Investigator
Facility:
Name:
Manipal Healthcare Group
Address:
City:
Goa
Country:
India
Contact:
Last name:
R.G. Pinto, MD
Email:
rgwpinto@gmail.com
Investigator:
Last name:
Sharmila Sardesai, MD
Email:
Principal Investigator
Investigator:
Last name:
R. G. Pinto, MD
Email:
Principal Investigator
Investigator:
Last name:
Eugene D'Silva, MD
Email:
Principal Investigator
Start date:
March 2011
Completion date:
March 2014
Lead sponsor:
Agency:
Woman's Cancer Foundation
Agency class:
Other
Source:
Woman's Cancer Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01178736
