NCT00632047

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151,538

participants targeted

Target at P75+ for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

August 26, 2013

Status Verified

July 1, 2009

Enrollment Period

17.6 years

First QC Date

March 7, 2008

Last Update Submit

August 23, 2013

Conditions

Breast CancerCervical Cancer

Keywords

breast cancercervical cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

active surveillanceOTHER
educational interventionOTHER
examinationPROCEDURE
long-term screeningPROCEDURE

Eligibility Criteria

Age35 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, 400012, India

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18408401RESULT

  • 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.

    PMID: 18408402RESULT

  • 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.

    PMID: 33627312DERIVED

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Interventions

Watchful WaitingEarly Intervention, EducationalRestraint, Physical

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Surendra S. Shastri, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
SCREENING
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 10, 2008

Study Start

May 1, 1998

Primary Completion

December 1, 2015

Last Updated

August 26, 2013

Record last verified: 2009-07

Locations

IN(1)