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Clinical Trials/CTRI/2016/04/006865
CTRI/2016/04/006865RecruitingNot Applicable

Early detection of breast cancer by self examination, clinical examination and fine needle aspiration cytology in rural women -a population based study

Rajeev Ghandhi University of Health Sciences1 site in 1 country1,000 target enrollmentStarted: December 8, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
awareness of early signs of breast cancer

Study Overview

Brief Summary

Breast cancer is now the commonest form cancer in women world over.  The rise in its incidence is remarkably steep in developing countries.  Breast cancer has emerged as the commonest cancer in urban Indian women and the second commonest among rural women. 1 Like the overall poor health awareness, awareness of breast cancer is poor among the masses.  This along with a general indifference towards the health of women, a lac of breast cancer screening program and delay in seeking advice for a recognized health problem for financial and social reasons results in delayed diagnosis2,3.  As a result, Indian breast cancer patients present with advanced disease and have numerous poor prognostic features such as large tumor, lymph node metastasis, high pathological grade and negative hormone receptors in many. 3.  Majority of the multimodality treatment cancer centres are concentrated in the larger cities.  Pathologist’ services like Fine Needle Aspiration Cytology are available mainly in the medical colleges.  This along with lack of awareness of about their own breasts in rural women brings them to the doctor in an advanced stage.  In Fr Muller Medical College Hospital, all the breast lumps are subjected to FNAC.  About 50 breast cancers are diagnosed annually with no false positive diagnosis and minimal false negative rate.  However more than 100 breast cancers are studied in histopathology section.  Surgeons from peripheral hospitals either send tru-cut or excision biopsies for diagnosis due to nonavailability of pathologists to do FNAC.  Therefore there is an urgent need to create awareness about breast cancer and provide services of pathologists to rural areas.  .

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 90.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •women above 20 years.

Exclusion Criteria

  • •Women who are already diagnosed with breast cancer.
  • •Pregnant and lactating women.

Outcomes

Primary Outcomes

awareness of early signs of breast cancer

Time Frame: ONE YEAR

early detection of breast cancer

Time Frame: ONE YEAR

Secondary Outcomes

  • reduction in mortality related to breast cancer(many years)

Investigators

Sponsor
Rajeev Ghandhi University of Health Sciences
Sponsor Class
Government funding agency

Study Sites (1)

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