| CTRI Number |
CTRI/2010/091/001205 [Registered on: 12/08/2010] |
| Last Modified On: |
21/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Early Detection of Common Cancers in Women in India |
|
Scientific Title of Study
|
Early Detection of Common Cancers in Women in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00632047 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Surendra S Shastri |
| Designation |
Professor and Head |
| Affiliation |
Department of Preventive Oncology |
| Address |
Department of Preventive Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
00912224154379 |
| Fax |
00912224146937 |
| Email |
shastri@vsnl.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Surendra S Shastri |
| Designation |
Professor and Head |
| Affiliation |
Department of Preventive Oncology |
| Address |
Department of Preventive Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
00912224154379 |
| Fax |
00912224146937 |
| Email |
shastri@vsnl.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Surendra S Shastri |
| Designation |
Professor and Head |
| Affiliation |
Department of Preventive Oncology |
| Address |
Department of Preventive Oncology
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
00912224154379 |
| Fax |
00912224146937 |
| Email |
shastri@vsnl.com |
|
|
Source of Monetary or Material Support
|
| RO1 Grant National Cancer Institute (NCI), USA |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital
Parel, Mumbai-400012,India
|
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Surendra S Shastri |
Tata Memorial Hospital |
Department of Preventive Oncology,Tata Memorial Hospital-400012
Mumbai
MAHARASHTRA |
+91-22-24154379
+91-22-24146937
shastri@vsnl.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board - I |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breast and Cervix cancer in Indian women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breast Cancer screening by clinical breast exam (CBE) and cervical cancer screening by visual inspection with acetic acid |
Screening for Breast cancer by Clinical breast examination and screening for cervical cancer by visual inspection after application of 5% acetic acid,provided by trained primary health workers |
| Comparator Agent |
Cancer Education |
Health education on breast and cervical cancer risks and early symptoms |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Female |
| Details |
1) Women between the ages of 35 and 64 years,
2) Who were living in the selected araes for more than one year and,
3) Who had no previous history of cancer.
|
|
| ExclusionCriteria |
| Details |
1) Women below 35 years and above 64 years.
2) Women who were staying in the area for less than a year
3) Women who had previous history of cancer |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Estimation of the downstaging
2)Mortality reduction
3)Screening participation rates
4)Participation rates for cancer education programs in the control group
5)Compliance rates to diagnostic confirmation and treatment acceptance and completion
6)Estimation of CBE and VIA positivity rates
7)Agreement rates between the FPHWs and expert physician for screening test performance
|
1)at the end of four rounds of screening
2)after completion of the study
3)every 24 months
4)at the end of first 24 months
5)every 24 months
6)every 24 months
7)every 24 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Cost-effectiveness analysis
2)Assessment of behavioral, cultural and psychological factors affecting participation of women in the trial |
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="151538"
Sample Size from India="151538"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/05/1998 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
24/05/1998 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="16"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Mittra I, Mishra GA, Singh S, Aranke S, Notani P, Badwe RA, Miller AB, Daniel EE, Gupta S, Uplap P, Thakur M, Ramani S, Kerkar R, Ganesh B, Shastri SS. A Cluster Randomized Controlled Trial of Cervix and Breast Cancer Screening in Mumbai, India: Methodology and Interim Analysis after Three Round of Screening, Int. J. Cancer 2010;126,4:976-84.
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 Randomized Controlled Trial On Screening Of Breast And Cervix Cancer In Mumbai, India. Compliance to Screening. Oncology 2007;73:145-153.
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 Randomized Controlled Trial On Screening Of Breast And Cervix Cancer In Mumbai, India. Compliance to Referral and Treatment. Oncology 2007;73:154-161.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary aim of this ongoing cluster randomized controlled trial, in urban slum women, aged 35-64 years, in Mumbai, India, is to investigate the efficacy of cancer education and screening, using affordable, sustainable and culturally acceptable techniques, i.e. Clinical Breast Examination (CBE) and Visual Inspection with 4% Acetic Acid (VIA), performed by trained female primary health workers (FPHWs) in the: 1) Early detection of breast and cervical cancer, 2) Downstaging of breast and cervical cancer, 3) Reduction in breast and cervical cancer mortality, 4) Reduction in cervical cancer incidence. The secondary aims of this trial are: 1) To estimate the cost and resource needs for conducting community-based cancer education and screening for breast and cervical cancers by CBE and VIA, 2) To study the behavioral, cultural and psychological factors affecting participation of women in such programs. |