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OpenTrials
Active, Not Recruiting

NCT Number: NCT05811169

Quest for Tumour Evolution of Non-small Cell Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Next generation sequencing

Genetic

Next generation sequencing

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

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

Registry information

Official study title

Quest for Tumour Evolution of Non-small Cell Lung Cancer in Chinese (Unicorn-Quest)

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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