RecruitingACTRN12610000028000

Utilization of 5HTT gene polymorphism as a prognostic indicator in cancer

Effect of 5HTT gene polymorphism on the progression-free survival of cancer patients

Sponsor

University of Alexandria

Enrollment

300 participants

Start Date

Dec 1, 2009

Study Type

Observational

Conditions

cancer. We are recruiting patients with a known primary cancer of the following types: lymphoma, lung, gastrointestinal tumours, genitourinary tumours, hepatocellular cancer, breast, nasopharyngeal cancers). Adjustment for cancer type in the statisticall analysis will be done by including cancer type in the regression model.

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

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a variation in a specific gene (called the 5-HTT gene, which is involved in how the brain handles the mood chemical serotonin) affects how cancer patients respond to treatment and how long they live without their cancer progressing. Some people with a particular version of this gene may be more prone to depression when under stress, and depression in cancer patients has been linked to worse outcomes. You may be eligible if: - You are 16 years of age or older - You have a known primary (original) cancer diagnosis - You are able and willing to give your consent - Your expected survival is more than 6 months You may NOT be eligible if: - You have a current diagnosis of a psychiatric condition or significant mental impairment - You are currently enrolled in another behavioural or psychosocial study Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Egypt

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ACTRN12610000028000