Early Detection of Breast Cancer and Cervical Cancer in Women in India
NCT ID: NCT00632047
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
151538 participants
INTERVENTIONAL
1998-05-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SCREENING
Interventions
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active surveillance
educational intervention
examination
long-term screening
Eligibility Criteria
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Inclusion Criteria
* Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
35 Years
64 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Tata Memorial Hospital
OTHER_GOV
Principal Investigators
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Surendra S. Shastri, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital
Locations
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Tata Memorial Hospital
Mumbai, , India
Countries
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Facility Contacts
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Surendra S. Shastri, MD
Role: primary
References
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Dinshaw K, Mishra G, Shastri S, Badwe R, Kerkar R, Ramani S, Thakur M, Uplap P, Kakade A, Gupta S, Ganesh B. Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in Mumbai, India. 1. Compliance to screening. Oncology. 2007;73(3-4):145-53. doi: 10.1159/000126497. Epub 2008 Apr 11.
Dinshaw K, Mishra G, Shastri S, Badwe R, Kerkar R, Ramani S, Thakur M, Uplap P, Kakade A, Gupta S, Ganesh B. Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in mumbai, India. 2. Compliance to referral and treatment. Oncology. 2007;73(3-4):154-61. doi: 10.1159/000126498. Epub 2008 Apr 11.
Mittra I, Mishra GA, Dikshit RP, Gupta S, Kulkarni VY, Shaikh HKA, Shastri SS, Hawaldar R, Gupta S, Pramesh CS, Badwe RA. Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai. BMJ. 2021 Feb 24;372:n256. doi: 10.1136/bmj.n256.
Other Identifiers
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TATA-1900215717A1
Identifier Type: -
Identifier Source: secondary_id
CDR0000586791
Identifier Type: -
Identifier Source: org_study_id