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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
Tata Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, cervical cancer

Eligibility Criteria

35 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
March 7, 2008
Last Updated
August 23, 2013
Sponsor
Tata Memorial Hospital
Collaborators
National Cancer Institute (NCI)
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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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