Early Detection of Cancers in Low Resource Countries

NCT01178736 | Unknown

• 1 other identifier: WCF-2011-BRA-IND-CAM
• Study Type: observational
• Target: 36,000
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Keywords

neoplasms

Outcome Measures

Primary Outcomes (1)

• The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology

  This study will examine the effectiveness of an innovative, low-cost screening and diagnostic methodology used for combined early detection of breast and gynecological cancers in low resource regions where early cancer detection strategies are not in place and cancers currently are diagnosed at advanced stages with resultant high mortality.

  Three (3) year interval

Secondary Outcomes (1)

• Effectiveness of CBE and Ultrasonography for Breast Cancer Detection

  Three (3) year interval

Study Arms (1)

Cancer Screening and Diagnosis

Screening of asymptomatic women for Breast and Cervical cancer in the age group of 35-64 years. Diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer in the age group of 50-64 years.

Procedure: Breast Cancer Screening and Diagnosis; Procedure: Cervical Cancer Screening and Diagnosis; Procedure: Ovarian Cancer Screening and Diagnosis; Procedure: Endometrial Cancer Screening and Diagnosis

Interventions

Breast Cancer Screening and Diagnosis PROCEDURE

Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.

Also known as: FNAB, CBE, Ultrasound

Cancer Screening and Diagnosis

Cervical Cancer Screening and Diagnosis PROCEDURE

Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.

Also known as: HPV DNA

Cancer Screening and Diagnosis

Ovarian Cancer Screening and Diagnosis PROCEDURE

Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.

Also known as: Ultrasound

Cancer Screening and Diagnosis

Endometrial Cancer Screening and Diagnosis PROCEDURE

Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.

Also known as: Ultrasound

Cancer Screening and Diagnosis

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• women under the age of 30

Sponsors & Collaborators

• Woman's Cancer Foundation: lead

Study Sites (3)

Hospital de Cancer de Barretos

São Paulo, Brazil

Location

Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia

Phnom Penh, Cambodia

Location

Manipal Healthcare Group

Goa, India

Location

Related Publications (17)

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MeSH Terms

Conditions

Breast Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Weiwei Yang, MD

  M.D. Anderson Cancer Center, University of Texas

  PRINCIPAL INVESTIGATOR

• Diljeet K Singh, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

• Adhemar Longatto Filho, MD

  University of Sao Paolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 10, 2010
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 10, 2010

Record last verified: 2010-08

Locations

BR (1); IN (1); CA (1)