Early Detection of Breast Cancer and Cervical Cancer in Women in India
Primary Purpose
Breast Cancer, Cervical Cancer
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
active surveillance
educational intervention
examination
long-term screening
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, cervical cancer
Eligibility 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
Sites / Locations
- Tata Memorial HospitalRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00632047
First Posted
March 7, 2008
Last Updated
August 23, 2013
Sponsor
Tata Memorial Hospital
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00632047
Brief Title
Early Detection of Breast Cancer and Cervical Cancer in Women in India
Official Title
Early Detection of Common Cancers in Women in India
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 1998 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tata Memorial Hospital
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
breast cancer, cervical cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Allocation
Randomized
Enrollment
151538 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
active surveillance
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Procedure
Intervention Name(s)
examination
Intervention Type
Procedure
Intervention Name(s)
long-term screening
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surendra S. Shastri, MD
Organizational Affiliation
Tata Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Surendra S. Shastri, MD
Phone
91-22-2415-4379
12. IPD Sharing Statement
Citations:
PubMed Identifier
18408401
Citation
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.
Results Reference
result
PubMed Identifier
18408402
Citation
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.
Results Reference
result
PubMed Identifier
33627312
Citation
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. Erratum In: BMJ. 2021 Mar 19;372:n738.
Results Reference
derived
Learn more about this trial
Early Detection of Breast Cancer and Cervical Cancer in Women in India
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