Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Educational/Counseling/Training, Screening Active 35 to 64 NCI TATA-1900215717A1 1900215717A1, NCT00632047

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India

Prior/Concurrent Therapy:

• Not specified

Patient Characteristics:

• Not specified

Expected Enrollment

Outcomes

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

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.

Dinshaw K, Mishra G, Shastri S, et al.: Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in Mumbai, India. 1. Compliance to screening. Oncology 73 (3-4): 145-53, 2007.[PUBMED Abstract]

Dinshaw K, Mishra G, Shastri S, et al.: 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 73 (3-4): 154-61, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Tata Memorial Hospital

Gauravi Mishra, MD, Principal investigator		Ph: 91-22-2415-7532

India
	Mumbai
	Tata Memorial Hospital
		Gauravi Mishra, MD	Ph:  91-22-2415-7532

Registry Information
Official Title		Early Detection of Common Cancers in Women in India
Trial Start Date		1998-05-04
Trial Completion Date		2015-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00632047
Date Submitted to PDQ		2008-02-07
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA074801