Utilization of 5HTT gene polymorphism as a prognostic indicator in cancer
Effect of 5HTT gene polymorphism on the progression-free survival of cancer patients
University of Alexandria
300 participants
Dec 1, 2009
Observational
Conditions
Summary
Cancer patients with curable/controllable disease who deteriorate without clinically detectable physical cause have led researchers to investigate the relation between depression and cancer progression. Studies showed an association between depression and cancer outcomes as decreased compliance, decreased desire for life-sustaining treatment and increased mortality. Lab studies show that neurotransmitters are capable of altering immune function whereas immune-derived mediators regulate neuroendocrine and autonomic outflow from the brain. Host cellular defenses against cancer involve immune mediated mechanisms that can be influenced by neurotransmitter activity. Caspi et al demonstrated that polymorphism of the 5-HTT gene explains why some individuals develop psychological morbidities on exposure to stressful life events while others exposed to the same conditions don't. This offers a screening criterion for identifying patients at risk for psychological morbidity that might be detrimental to their treatment outcome and may be used as a prognostic indicator in which case, starting anti-cancer treatment of this group of patients with concurrent psychological intervention may improve their treatment outcomes. AIM: To study the role of 5HTT gene as a prognostic indicator in cancer and its utilization for clinical selection of patients for concurrent psychotherapy with anticancer treatment. METHOD: A longitudinal observational study in which cancer outcomes are compared in two independent cohorts of cancer patients grouped by 5HTT genotype (patients with two long alleles versus those with at least one short allele). OUTCOMES: Primary outcome measure is progression free survival. Secondary outcomes are response to treatment, functional and psychological status of the patient as expressed by Quality of Life (QOL) measurement using FACT-G questionnaire and Hospital Anxiety and Depression Scale (HADS) questionnaire, and overall survival.
Eligibility
Inclusion Criteria5
- Over 16 years of age
- Have a known primary cancer
- Able and willing to give consent
- Life expectancy more than 6 months
- For study 2, an additional criterion will be added: the possession of at least one short allele of the 5HTT gene.
Exclusion Criteria1
- Patients are considered ineligible if they have overt psychopathology or mental impairment at enrollment into the study, or if they are enrolled in other behavioural or psychosocial studies
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Interventions
We are registering the first part of the research program which is an observational phase where differences in outcome between patients with at least one short allele of the 5HTT gene are compared to patients with long aleles. Patients will be observed for two years. Assessment of response rate, progression-free survival, quality of life outcomes and overall survival will be conducted at baseline, 6 months, 1 year and 2 years. A planned second stage is an interventional stage where patients with at least one short allele are randomised to an intervention arm that starts their treatment with a concurrent comprehensive psychiatric care program and a control arm that receives standard treatment (without the psychiatric intervention)
Locations(1)
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ACTRN12610000028000