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Early Detection of Breast Cancer and Cervical Cancer in Women in India

Early Detection of Common Cancers in Women in India

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00632047
Enrollment
151538
Registered
2008-03-10
Start date
1998-05-31
Completion date
Unknown
Last updated
2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cervical Cancer

Keywords

breast cancer, cervical cancer

Brief summary

RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer. PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

Detailed description

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.

Interventions

OTHERactive surveillance
OTHEReducational intervention
PROCEDUREexamination

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Primary purpose
SCREENING

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026