Clinical trial NCT05811169: Quest for Tumour Evolution of Non-small Cell Lung Cancer
Official title: Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer
Keywords: Next Generation Sequencing
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
name: Pamela Youde Nethersole Eastern Hospital
name: Prince of Wales Hospital, Shatin, Hong Kong
name: Princess Margaret Hospital, Hong Kong
name: Tuen Mun Hospital
name: United Christian Hospital
First posted: 2023-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage I to IVB non-squamous non-small cell lung cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intratumour heterogeneity
timeFrame: 5 years
measure: Intertumour heterogeneity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Victor Ho-Fun Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: