Quest for Tumour Evolution of Non-small Cell Lung Cancer
April 11, 2023 updated by: The University of Hong Kong
Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Department of Clinical Oncology, Queen Mary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Stage I to IVB non-squamous non-small cell lung cancer
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Early or metastatic non-small cell lung cancer
The formalin-fixed paraffin-embedded specimen will be retrieved for next generation sequencing.
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Next generation sequencing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intratumour heterogeneity
Time Frame: 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
|
5 years
|
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Intertumour heterogeneity
Time Frame: 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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Victor Ho-Fun Lee, MD, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
February 26, 2023
First Submitted That Met QC Criteria
April 11, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 20-145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.