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Early Detection of Common Cancers in Women in India


Phase 2
35 Years
64 Years
Open (Enrolling)
Female
Breast Cancer, Cervical Cancer

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Trial Information

Early Detection of Common Cancers in Women in India


OBJECTIVES:

- To investigate the effectiveness of well planned health education programs (HEP) and
low-cost screening methods (e.g., clinical breast examination [CBE] and visual
inspection of the cervix painted with 4% acetic acid [VIA]) in down-staging and
reducing the incidence of and mortality due to breast and cervical cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

- Arm I (intervention): Participants undergo intervention comprising health education
programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix
painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also
undergo active surveillance over 8 years.

- Arm II (control): Participants receive one HEP. Participants also undergo active
surveillance over 8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Screening

Outcome Measure:

Effectiveness of well planned health education programs and low-cost screening methods (e.g., clinical breast exam and visual inspection of the cervix) in reducing the incidence of and mortality due to breast and cervical cancer

Safety Issue:

Yes

Principal Investigator

Surendra S. Shastri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital

Authority:

Unspecified

Study ID:

CDR0000586791

NCT ID:

NCT00632047

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • Cervical Cancer
  • breast cancer
  • cervical cancer
  • Breast Neoplasms
  • Uterine Cervical Neoplasms

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