Lung Cancer Clinical Trial
Official title:
Use of the Biocartis Idylla ™ Platform for the Detection of Epidermal Growth Factor Receptor, B-RAF and K-RAS Proto-oncogene Mutations in Liquid Based Cytology Specimens and Blood Plasma Samples From Patients With Non Small Cell Lung Carcinoma and Pancreatic Adenocarcinoma
Verified date | February 2021 |
Source | Royal Cornwall Hospitals Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Use of the Biocartis Idylla ™ platform for the detection of Epidermal Growth Factor Receptor, B-RAF and K-RAS proto-oncogene mutations in liquid based cytology specimens and blood plasma samples from patients with non small cell lung carcinoma and pancreatic adenocarcinoma.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 7, 2022 |
Est. primary completion date | March 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Cytological / histological diagnosis of non small cell lung carcinoma or pancreatic adenocarcinoma - Patients of any gender ethnicity or socioeconomic grouping - Patients over the age of 18 years Exclusion Criteria: - Other malignancies (Not non small cell lung carcinoma or pancreatic adenocarcinoma) - Benign diagnosis - Patients under the age of 18 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Cornwall Hospital | Truro | Cornwall |
Lead Sponsor | Collaborator |
---|---|
Royal Cornwall Hospitals Trust | Biocartis |
United Kingdom,
De Luca C, Gragnano G, Pisapia P, Vigliar E, Malapelle U, Bellevicine C, Troncone G. EGFR mutation detection on lung cancer cytological specimens by the novel fully automated PCR-based Idylla EGFR Mutation Assay. J Clin Pathol. 2017 Apr;70(4):295-300. doi — View Citation
Hadano N, Murakami Y, Uemura K, Hashimoto Y, Kondo N, Nakagawa N, Sueda T, Hiyama E. Prognostic value of circulating tumour DNA in patients undergoing curative resection for pancreatic cancer. Br J Cancer. 2016 Jun 28;115(1):59-65. doi: 10.1038/bjc.2016.1 — View Citation
Sausen M, Phallen J, Adleff V, Jones S, Leary RJ, Barrett MT, Anagnostou V, Parpart-Li S, Murphy D, Kay Li Q, Hruban CA, Scharpf R, White JR, O'Dwyer PJ, Allen PJ, Eshleman JR, Thompson CB, Klimstra DS, Linehan DC, Maitra A, Hruban RH, Diaz LA Jr, Von Hof — View Citation
Zhao H, Qiu T, Guo H, Ying J, Li J, Zhang Z. Detection of EGFR and KRAS gene mutations using suspension liquid-based cytology specimens in metastatic lung adenocarcinoma. Oncotarget. 2017 Nov 20;8(63):106685-106692. doi: 10.18632/oncotarget.22530. eCollection 2017 Dec 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of participants with negative and positive mutation status for KRAS, EGFR and BRAF in LBC samples detected using the BioCartis Idylla Platform real time PCR kits. | 1. Can the Idylla platform provide a standardised and effective method for detecting EGFR, KRAS and BRAF mutations in liquid based cytology samples for patients with lung and pancreatic cancer. Mutation detection increases the treatment options for patients. | 24 months | |
Primary | The number of patients with a positive KRAS mutation status in Cytolgy clot samples reported as pancreatic adenocarcinoma, using the Biocartis Idylla platform real time PCR kits. | 2. Establish the mutation prevalence in population served by the Royal Cornwall Hospital. This could provide an avenue for drug development to treat pancreatic cancers | 24 months | |
Primary | The number of participants with negative and positive mutation status for KRAS, EGFR and BRAF in blood plasma samples detected using the BioCartis Idylla Platform real time PCR kits. | 3. Testing for mutations in the blood samples and directly comparing it with mutations seen in the cytology samples, will provide valuable information in the reliance of blood tests for cancer diagnosis. Potentially eliminating the need for invasive procedures in the future. | 24 months |
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