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

Breast Cancer Clinical Trial

Official title:

Early Detection of Common Cancers in Women in India

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00632047
• Other study ID #: CDR0000586791
• Secondary ID: TATA-1900215717A
• Status: Recruiting
• Phase: Phase 2
• First received: March 7, 2008
• Last updated: August 23, 2013
• Start date: May 1998

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 151538
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• active surveillance

• educational intervention

Procedure:
• examination

• long-term screening

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Tata Memorial Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

India, 

References & Publications (2)

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 sc — View 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 re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			Yes