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Not Yet Recruiting
NCT07661251
ITTACA (Immunotherapy Time Teller for Advanced Lung Cancer)
Conditions: Non-Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Laura Longshaw
Summary
Immunotherapy is a relatively new treatment that uses patients' own immune systems to fight diseases, particularly cancers.
Recent studies suggest that the effectiveness of immunotherapy in cancer treatment may depend on the time of day it is given.
This observational study wants to explore this further by looking at the effectiveness of immunotherapy in lung cancer patients in relation to their circadian rhythms. A circadian rhythm is the body's natural internal clock that regulates sleep, wakefulness, hormones, temperature and other bodily functions. They are roughly 24 hours long and respond to environmental cues, such as light and dark.
An individual's circadian rhythm can be described by their chronotype which is their natural inclination to sleep at certain times of the day. Some people are 'early birds' or 'larks' and others are 'night owls'.
It is usually difficult to determine a person's chronotype. A new tool has been developed by Warwick University called 'TimeTeller'. This study will see if TimeTeller can provide a non-invasive, practical, accurate and clinically relevant method to find out a person's chronotype by investigating specific genes in a single hair follicle or cheek swab sample.
The study also aims to explore if different chronotypes respond better to immunotherapy treatments. Furthermore, it will look at whether immunotherapy changes the circadian rhythm.
The results of this study may lead to further research in the future to explore how the timing of immunotherapy can work better for each individual. Additionally, it may provide greater insight into the impact immunotherapy has on human body clocks.
Eligibility Criteria
Inclusion Criteria:
* Histological diagnosis of NSCLC, stage IIIB-IV NSCLC, receiving pembrolizumab, atezolizumab and nivolumab (+/- chemotherapy) as, adjuvant, neoadjuvant or palliative treatment at Ysbyty Gwynedd
* WHO performance status (PS) \2
* Uncontrolled comorbidities
* Lacking capacity
* Inability to wear biosensor bracelet
* Complete alopecia.
Source: ClinicalTrials.gov (NCT07661251). StuddyBuddy aggregates publicly available trial information.