Quest for Tumour Evolution of Non-small Cell Lung Cancer

Sponsor
The University of Hong Kong (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05811169
Collaborator
Queen Mary Hospital, Hong Kong (Other), Queen Elizabeth Hospital, Hong Kong (Other), Pamela Youde Nethersole Eastern Hospital (Other), Prince of Wales Hospital, Shatin, Hong Kong (Other), Princess Margaret Hospital, Hong Kong (Other), Tuen Mun Hospital (Other), United Christian Hospital (Other)
60
1
46.5
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Next generation sequencing

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Early or metastatic non-small cell lung cancer

The formalin-fixed paraffin-embedded specimen will be retrieved for next generation sequencing.

Genetic: Next generation sequencing
Next generation sequencing

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Oncology, Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong
  • Queen Mary Hospital, Hong Kong
  • Queen Elizabeth Hospital, Hong Kong
  • Pamela Youde Nethersole Eastern Hospital
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Princess Margaret Hospital, Hong Kong
  • Tuen Mun Hospital
  • United Christian Hospital

Investigators

  • Principal Investigator: Victor Ho-Fun Lee, MD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05811169
Other Study ID Numbers:
  • UW 20-145
First Posted:
Apr 13, 2023
Last Update Posted:
Apr 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2023