Health Condition 1: null- Oral Head and Neck Cancers
Conditions
Interventions
None listed
Sponsors
Dr Samir Khariwala
Eligibility
Inclusion criteria
Inclusion criteria: a. Male of female adult SLT users b. Used the same product variety for more than 80% of their smokeless tobacco over the course of at least 1 year, and used this variety at least 2 weeks prior to the eligibility screening c. Not smoking or using any other nicotine or tobacco product. d. subjects in stable and good mental health (i.e. capable to understand the study, consent and complete study procedures) e.Subjects who have provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: a. Regular smoking or tobacco use (e.g. greater than weekly) other than usual SLT products. b. Currently using nicotine replacement or other tobacco cessation products ( to minimize confounding effects of another product) c. Pregnant women d. Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To measure the variation in NNN and NNK levels across tobacco products. 2. To prove that after adjustment for duration and intensity of product use, higher carcinogen levels in SLT products will lead to higher biomarker levels in users. 3. To prove that OHNC patients will have higher levels of biomarkers than SLT users without cancer. Timepoint: Spot sampling (once only) | — |
Secondary
| Measure | Time frame |
|---|---|
| Capacity building and sustained collaboration 1. National tobacco product repository at Healis-Sekhsaria Institute for Public Health in Mumbai 2. Biospecimen repository: Samples collected from SLT users will be part of the biospecimen repository which will be hosted by the Tata Memorial Hospital 3.Strengthening laboratory capacity at ACTREC will serve not only to complete the proposed studies, but also as a critical long-term resource for other tobacco exposure studies in India.Timepoint: Not applcable | — |
Countries
India
Contacts
Public ContactDr Pankaj Chaturvedi
Advanced Centre for Treatment, Research and Education in Cancer
Outcome results
None listed