Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma

National University Health System (NUHS)

Status: Unknown

Conditions: Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Lung

Study type: Observational

Funder types: Other

Identifiers

NCT03938012

2017/00640

Details and patient eligibility

About

This study focuses on advanced lung and head and neck SCC tumours, with adjacent normal lung tissues. Biopsies will be performed in National University Health System, Singapore (NUHS) as part of participants' standard care. Patient blood was also required for extraction of cell free DNA (cfDNA) and genomic DNA (gDNA). Patients' medical records will also be reviewed for the purpose of this study.

Full description

Primary objective:

To investigate the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in lung and head and neck tumours, through prospective collection of tumour specimens in newly recruited patients.

Secondary objectives:

1. To distinguish the presence of somatic/germline MET and TP53 mutation in lung and head and neck tumours.
2. To detect for amplifications of MET and/or HER2 genes in SCC samples.
3. To investigate the association and interaction of cMet and HER2 in SCC tumours.
4. To establish a prospective documation of clinical, histopathological, treatment and follow-up (clinic pathological) data of newly recruited patients.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older
2. Histologic or cytologic confirmation of metastatic squamous cell carcinoma of the lung or head and neck region
3. No other active malignancy within the past 24 months
4. Refractory disease

Exclusion criteria

1. Patient with other active malignancy within the past 24 months
2. Unable or unwilling to provide signed informed consent

Trial design

80 participants in 1 patient group

Lung and head and neck tumours

Description:

1. Age 18 years or older 2. Histologic or cytologic confirmation of metastatic squamous cell carcinoma of the lung or head and neck region 3. No other active malignancy within the past 24 months 4. Refractory disease