Ca Hypopharyngeal and Esophagus Screening Trial (CHEST)

The people from Ratnagiri district will be participating in screening camps arranged in each village, wherein they will be screened for 'Double contrast Barium Swallow'.

Background
  • Esophageal and Hypopharyngeal cancer are amongst the five leading cancers in India. In Dibrugarh Assam registry they both togather lead the list of cancers.
  • Hypopharynx cancers are commoner in the developing countries as compared to the western region.
  • There is no screening policy in place for these cancers and they are mostly diagnosed in advanced stages.
Ca Hypopharyngeal and Esophagus Screening Trial (CHEST)
Project goals

Use of double contrast barium swallow as a screening tool to reduce cancer related mortality due to esophageal and hypopharyngeal cancers.

Project objectives

To Assess

  • Improvement in survival after diagnosis of esophageal and hypopharyngeal cancers.
  • Sensitivity and Specificity of double contrast barium swallow (with spot film) in diagnosis of asymptomatic esophageal and hypopharyngeal cancers.
  • Cost-effectiveness of mass screening for the above said cancers in the community.
  • Identification of possible etiological factors for the above said cancers.
Outcomes of our project
  • Reduction in Esophageal and hypopharyngeal cancers related mortality.
  • Improvement in the prognosis of the above said cancers.
  • Effectiveness of DDCBS for diagnosis of the above said cancers.
  • Affordability of the screening process for the above said cancers.
  • To obtain associations between possible lifestyle and socio-demographic factors for causation of the above said cancers.
Project Design and Implementation
  • Study Design: Prospective community based cluster randomized clinical trial
  • Collaborating Institution: BKLW Hospital, Dervan
  • Study Site: Ratnagiri District.
    - Clusters will be formed and randomised into two arms. - Base Hospital: BKLW Hospital, Dervan, Chiplun
Eligible subjects
  • Healthy
  • Ambulant men and women
  • Tobacco and Alcohol users as risk factors
  • Permanent residents in the chosen clusters.
Inclusion Criteria
  • Subjects with risk factor exposure for esophageal and hypopharyngeal cancers-
  • Chronic tobacco users (cumulative use of more than 5 years)
  • Betel and areca nut chewers
  • Alcohol use (cumulative more than 5 years)
  • Age: 35-65 years.
Study Groups

Group 1: Control Arm
Group 2: Screening Arm

Sample Size: -55,000 subjects in each arm
-7500 subjects in each cluster (approximately).
-7 clusters in each arm

Control Arm
  • This is an Observation arm.
  • No active intervention is going to be provided to the subjects in this arm.
  • Subjects selected for this arm will be similar to the subjects of the screening arm in all respects.
  • The subjects of this arm will receive health education and counseling regarding the harmful effects of tobacco and alcohol.
Screening Arm
  • The subjects of this arm will receive health education and counseling regarding the harmful effects of alcohol and tobacco.
  • The subjects will also receive awareness sessions on cancer diagnosis and the follow up for positive cases emphasizing compliance to the study and requisite follow-up.
  • The subjects of this arm will also receive an intervention.
Place of Screening
  • In the selected community.
  • MESU (Mobile Esophageal Screening Unit) with a digital radiography machine installed will be used for this study.
  • Images obtained will be interpreted and reported by a qualified radiologist
Follow-up Schedule
  • 2 rounds of screening
  • 1st round-1st -3rd years
  • 2nd round- 4th -6th Year
  • Follow- up surveillance -4 years.
Documentation
  • Household Survey Form
  • Eligibles register
  • Registration Registers
  • History sheet
  • Screening Form
  • Follow-up registers
  • Hospital Documentations
Study protocol, Logistics for the Hypopharyngeal and Esophagus cancer screening study.
Identifying Stake holders
  • Listing of Stakeholders
  • Contact programmes with Stake holders
  • Project Information material for Stake holders
  • Planning Awareness sessions for Stake holders
Health Education Program
  • Health Education material for general population awareness programmes.
  • Different mediums and tools for general population awareness programmes.
  • Organisation of Health Education programmes (Day time & Night Time)
  • Formation of Teams
Household Surveys for Eligible population
  • Household Survey forms
  • Eligible population listing: current and compatibility
  • Check list for completeness of Survey
Screening Forms
  • Screening forms data collection
  • Defining Eligibility criteria
  • Check list for completeness of Forms
Summary
  • Of the total 34332 eligible, 20554(60%) attended DCBS screening.
  • 37(0.2%) screen positive, 37(100%) attended follow up , 16 cancer cases detected (0.08). Out of 16 cancer cases, 15(93.8%) cases completed treatment.
  • Follow up of DCBS screening from Ratangiri cluster is going on.
  • Oral Cancer Screening is in process at Lanja, Mandangad and at Dapoli.
  • Of the total 48402 eligible, 34467 (71.2%) attended oral cancer screening. 809 (2.3%) screen positive, 719(89%) attended follow up. 21(0.06%) cancer cases detected.
  • Out of 21 oral cancer cases 17 (81%) cases has completed treatment.
  • In the control arm, 22377 eligible recruited.
  • The cancer cases data collection in intervention arm and control is in process.
  • The mortality data collection is in process.