Early Detection of Breast Cancer and Cervical Cancer in Women in India
This study is currently recruiting participants.
Verified July 2009 by National Cancer Institute (NCI)
Sponsor:
Tata Memorial Hospital
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632047
First received: March 7, 2008
Last updated: December 24, 2009
Last verified: July 2009
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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: active surveillance Other: educational intervention Procedure: examination Procedure: long-term screening |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Screening |
| Official Title: | Early Detection of Common Cancers in Women in India |
Resource links provided by NLM:
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) |
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
Investigators
| Principal Investigator: | Surendra S. Shastri, MD | Tata Memorial Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00632047 History of Changes |
| Other Study ID Numbers: | CDR0000586791, TATA-1900215717A1 |
| Study First Received: | March 7, 2008 |
| Last Updated: | December 24, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
breast cancer cervical cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Uterine Cervical Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013