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

NCT ID: NCT03938012

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Squamous Cell Carcinoma of the Lung Squamous Cell Carcinoma of the Head and Neck

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung and head and neck tumours

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boon Cher Goh

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Boon Cher Goh

Role: CONTACT

6779 5555

Facility Contacts

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Boon Cher Goh, MBBS, MRCP

Role: primary

65-6772-4617

References

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Stransky N, Egloff AM, Tward AD, Kostic AD, Cibulskis K, Sivachenko A, Kryukov GV, Lawrence MS, Sougnez C, McKenna A, Shefler E, Ramos AH, Stojanov P, Carter SL, Voet D, Cortes ML, Auclair D, Berger MF, Saksena G, Guiducci C, Onofrio RC, Parkin M, Romkes M, Weissfeld JL, Seethala RR, Wang L, Rangel-Escareno C, Fernandez-Lopez JC, Hidalgo-Miranda A, Melendez-Zajgla J, Winckler W, Ardlie K, Gabriel SB, Meyerson M, Lander ES, Getz G, Golub TR, Garraway LA, Grandis JR. The mutational landscape of head and neck squamous cell carcinoma. Science. 2011 Aug 26;333(6046):1157-60. doi: 10.1126/science.1208130. Epub 2011 Jul 28.

Reference Type RESULT
PMID: 21798893 (View on PubMed)

Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012 Sep 27;489(7417):519-25. doi: 10.1038/nature11404. Epub 2012 Sep 9.

Reference Type RESULT
PMID: 22960745 (View on PubMed)

Other Identifiers

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2017/00640

Identifier Type: -

Identifier Source: org_study_id

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