Early Detection of Breast Cancer and Cervical Cancer in Women in India - Full Text View

Sponsors and Collaborators:	Tata Memorial Hospital National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00632047

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Cervical Cancer	Other: educational intervention Procedure: examination Procedure: long-term screening Procedure: observation	Phase II

Study Type:	Interventional
Study Design:	Screening, Randomized
Official Title:	Early Detection of Common Cancers in Women in India

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: Yes ]

Estimated Enrollment:	151538
Study Start Date:	May 1998
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	35 Years to 64 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632047

Locations

India
Tata Memorial Hospital	Recruiting
Mumbai, India, 400012
Contact: Surendra S. Shastri, MD 91-22-2415-4379

Sponsors and Collaborators

Tata Memorial Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Surendra S. Shastri, MD

Tata Memorial Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. 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. Epub 2008 Apr 11.

Study ID Numbers:	CDR0000586791, TATA-1900215717A1
Study First Received:	March 7, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00632047 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer
cervical cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009