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Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries


Phase 0
30 Years
64 Years
Not Enrolling
Female
Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms

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Trial Information

Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Three (3) year interval

Safety Issue:

No

Principal Investigator

Weiwei Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center, University of Texas

Authority:

Brazil: Ministry of Health

Study ID:

WCF-2011-BRA-IND-CAM

NCT ID:

NCT01178736

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Breast Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma

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