Quest for Tumour Evolution of Non-small Cell Lung Cancer

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Genetic: Next generation sequencing

• Registration Number: NCT05811169
• Lead Sponsor: The University of Hong Kong

Brief Summary

To study and comprehend the evolutionary and genomic landscape between primary and metastatic sites and the dynamics of intratumour and intertumour heterogeneity over time with reference to the treatment modalities for each Chinese patient with non-small cell lung cancer.

Detailed Description

The importance of intratumour and intertumour heterogeneity in non-small cell lung cancer has been extensively interrogated recently. However there is a lack of similar data associated with treatment and survival outcomes in Chinese population. Unicorn-Quest, a prospective observational study of Chinese patients with either primary or metastatic non-small cell lung cancer, aims to identify the evolutionary changes from the primary tumour, regional nodes and distant metastases of the same patients and among different patients, through multiregion and longitudinal tumour and nodal collection with next-generation sequencing. By following non-small cell lung cancer from early stage to relapse or distant metastasis, identifying the changes of genomic landscape with correlation with treatment and survival outcomes, this study may help identify unique cancer trajectories and novel therapeutic targets for non-small cell lung cancer in Chinese population.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-15
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Written Informed consent
• Patients ≥18 years of age, with histologically confirmed non-squamous non-small cell lung cancer who plan to receive active anti-cancer treatment for their non-small cell lung cancer.
• Sufficient tissues with a minimum of two tumour or nodal regions are available for the study based on pre-operative imaging and post-operative pathological findings.

Exclusion Criteria

• Any other* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).

Any other* current malignancy or malignancy diagnosed or relapsed within the past 3 years**.

*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer

**An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.

• Psychological condition that would preclude informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early or metastatic non-small cell lung cancer	Next generation sequencing	The formalin-fixed paraffin-embedded specimen will be retrieved for next generation sequencing.

Primary Outcome Measures

Name	Time	Method
Intratumour heterogeneity	5 years	Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations within the same groups of patients with early and metastatic non-small cell lung cancer
Intertumour heterogeneity	5 years	Number of participants who have single actionable and non-actionable genetic mutations and multiple actionable and non-actionable genetic mutations of different groups of patients with early and metastatic non-small cell lung cancer

Trial Locations

Locations (1)

Department of Clinical Oncology, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong