Early Detection of Cancers in Low Resource Countries
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ClinicalTrials.gov Identifier: NCT01178736 |
Recruitment Status
: Unknown
Verified August 2010 by Woman's Cancer Foundation.
Recruitment status was: Not yet recruiting
First Posted
: August 10, 2010
Last Update Posted
: August 10, 2010
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Condition or disease | Intervention/treatment |
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Breast Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Endometrial Neoplasms | Procedure: Breast Cancer Screening and Diagnosis Procedure: Cervical Cancer Screening and Diagnosis Procedure: Ovarian Cancer Screening and Diagnosis Procedure: Endometrial Cancer Screening and Diagnosis |
Study Type : | Observational |
Estimated Enrollment : | 36000 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | March 2014 |
Group/Cohort | Intervention/treatment |
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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.
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Procedure: Breast Cancer Screening and Diagnosis
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
Other Names:
Procedure: Cervical Cancer Screening and Diagnosis
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
Other Name: HPV DNA
Procedure: Ovarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Other Name: Ultrasound
Procedure: Endometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Other Name: Ultrasound
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- The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology [ Time Frame: Three (3) year interval ]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.
- Effectiveness of CBE and Ultrasonography for Breast Cancer Detection [ Time Frame: Three (3) year interval ]This study will examine the effectiveness of Clinical Breast Examination combined with Ultrasonography for breast cancer screening and detection in low resource settings where X-ray mammography proves not feasible in terms of cost, technology, and staff.

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Ages Eligible for Study: | 30 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178736
Brazil | |
Hospital de Cancer de Barretos | Not yet recruiting |
Sao Paolo, Brazil | |
Contact: Edmundo Mauad, MD, PhD (17) 3321-6600 ecmauad@hcancerbarretos.com.br | |
Principal Investigator: Edmundo Mauad, MD, PhD | |
Cambodia | |
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia | Not yet recruiting |
Phnom Penh, Cambodia | |
Contact: Cornelia Haener, MD (855-23) 882-484 corneliahaener@sihosp.org | |
Contact: Shelly Malhotra shellymalhotra@sihosp.org | |
Principal Investigator: Cornelia Haener, MD | |
India | |
Manipal Healthcare Group | Not yet recruiting |
Goa, India | |
Contact: R.G. Pinto, MD rgwpinto@gmail.com | |
Principal Investigator: Sharmila Sardesai, MD | |
Principal Investigator: R. G. Pinto, MD | |
Principal Investigator: Eugene D'Silva, MD |
Principal Investigator: | Weiwei Yang, MD | M.D. Anderson Cancer Center, University of Texas | |
Principal Investigator: | Diljeet K Singh, MD | Feinberg School of Medicine, Northwestern University | |
Principal Investigator: | Adhemar Longatto Filho, MD | University of Sao Paolo |
Publications:
Responsible Party: | Mahesh Shetty, MD/President, Woman's Cancer Foundation |
ClinicalTrials.gov Identifier: | NCT01178736 History of Changes |
Other Study ID Numbers: |
WCF-2011-BRA-IND-CAM |
First Posted: | August 10, 2010 Key Record Dates |
Last Update Posted: | August 10, 2010 |
Last Verified: | August 2010 |
Keywords provided by Woman's Cancer Foundation:
neoplasms |
Additional relevant MeSH terms:
Neoplasms Breast Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Endometrial Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Uterine Neoplasms Uterine Cervical Diseases Uterine Diseases |