Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057914) titled 'Prospective observational study investigating the significance of the epigenetic clock in treatment-naive patients with non-small cell lung cancer receiving immune checkpoint blockade therapy' on July 31.

Study Type: Observational

Primary Sponsor: Institute - Hamamatsu University School of Medicine

Condition: Condition - Non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the association between biological age assessed prior to immune checkpoint blockade therapy and treatment efficacy in patients with advanced non-small cell lung cancer. Additionally, the study will investigate the relationship between biological age, general condition, and quality of life (QOL), as well as changes in biological age induced by treatment. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients must meet all of the following criteria: 1. Age equal to or more than 20 years at the time of consent. 2. Histologically or cytologically confirmed diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with no prior systemic treatment. 3. Planned to receive first-line immune checkpoint blockade, including anti-PD-1/PD-L1 antibodies as monotherapy, in combination with chemotherapy, or in combination with anti-CTLA-4 antibodies. 4. Ability to provide written informed consent for participation in this study. Key exclusion criteria - Patients who meet any of the following criteria will be excluded from the study: 1. Severe renal impairment (eGFR < 30 mL/min/1.73 m), including those undergoing hemodialysis. 2. Presence of active malignancies other than non-small cell lung cancer. 3. History of systemic therapy or radiotherapy for lung cancer or any other malignancy within the past 6 months (excluding palliative radiation for the non-small cell lung cancer being studied). 4. Prior treatment with immune checkpoint inhibitors. 5. Pregnant women or women who may be pregnant. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 20 Day Anticipated trial start date - 2025 Year 07 Month 08 Day Last follow-up date - 2030 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066204

Disclaimer: Curated by HT Syndication.