Quest for Tumour Evolution of Non-small Cell Lung Cancer

NCT05811169 | Active Not Recruiting

• 1 other identifier: UW 20-145
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Next Generation Sequencing

Outcome Measures

Primary Outcomes (2)

• Intratumour heterogeneity

  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

• Intertumour heterogeneity

  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

Study Arms (1)

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

Interventions

Next generation sequencing GENETIC

Next generation sequencing

Early or metastatic non-small cell lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage I to IVB non-squamous non-small cell lung cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

The formalin-fixed paraffin embedded tumour and lymph node samples of non-small cell lung cancer as well as blood, plasma and serum samples are retrieved and collected for next-generation sequencing

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Victor Ho-Fun Lee, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: April 13, 2023
• Study Start: February 15, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)