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| Name | Class |
|---|---|
| Tempus AI | INDUSTRY |
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The objective of the LOLA Project is to analyse the impact of adopting xF liquid biopsy panel, in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost through the assessment of clinical impact, duration of turnaround time (TAT) of xF test vs standard of care and the analysis of resource utilisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with radiologic evidence of metastatic (stage IV) NSCLC |
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| Patients with radiologic evidence of metastatic (stage IV) CRC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xF Tempus assay | Diagnostic Test | The blood will be collected and sent to Tempus Labs using the standard sample collection kit containing all the necessary elements to guarantee shipment to Tempus Labs. Two Streck tubes with 8.5mL of blood per tube will be sent to Tempus Labs. The ctDNA isolation and automatic library preparation will be performed using TEMPUS technology (Finkel et al 2021). The NGS analyses will be developed using the xF Tempus assay. This assay involves a panel with hybrid gene capture that detects actionable oncologic targets in four variant classes: single-nucleotide variants (SNVs), insertions/deletions (indels), copy number variants (CNVs), and gene rearrangements. The NGS sequencing is performed using NovaSeq 6000Dx Sequencing System (Illumina, Inc) equipment, according to Tempus protocols. (Finkel et al 2021). |
| Measure | Description | Time Frame |
|---|---|---|
| To analyse the impact of adopting large (TEMPUS) NGS panels in the real world of the Andalusian Health Public System in terms of impact on clinical practice and cost. | Proportion of patients with at least one actionable variant (%) | through study completion, an average of 3 year |
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Inclusion Criteria:
General criteria:
Specific criteria:
NSCLC
CRC
Exclusion Criteria:
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Metastatic adenocarcinoma (NSCLC: 250 and CRC: 250)
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| Name | Affiliation | Role |
|---|---|---|
| M Jose Serrano, PhD | Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves | Principal Investigator |
| Valeria Denninghoff, PhD | Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) | Granada | Andalusia | 18016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32428812 | Background | Rolfo C, Cardona AF, Cristofanilli M, Paz-Ares L, Diaz Mochon JJ, Duran I, Raez LE, Russo A, Lorente JA, Malapelle U, Gil-Bazo I, Jantus-Lewintre E, Pauwels P, Mok T, Serrano MJ; ISLB. Challenges and opportunities of cfDNA analysis implementation in clinical practice: Perspective of the International Society of Liquid Biopsy (ISLB). Crit Rev Oncol Hematol. 2020 Jul;151:102978. doi: 10.1016/j.critrevonc.2020.102978. Epub 2020 May 5. | |
| 38170059 |
| Label | URL |
|---|---|
| Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Streck tubes with 8.5mL of blood
|
| Background |
| Rolfo C, Denninghoff V. Globalization of precision medicine programs in lung cancer: a health system challenge. Lancet Reg Health Eur. 2023 Dec 12;36:100819. doi: 10.1016/j.lanepe.2023.100819. eCollection 2024 Jan. No abstract available. |
| 33781866 | Background | Pisapia P, Costa JL, Pepe F, Russo G, Gragnano G, Russo A, Iaccarino A, de Miguel-Perez D, Serrano MJ, Denninghoff V, Quagliata L, Rolfo C, Malapelle U. Next generation sequencing for liquid biopsy based testing in non-small cell lung cancer in 2021. Crit Rev Oncol Hematol. 2021 May;161:103311. doi: 10.1016/j.critrevonc.2021.103311. Epub 2021 Mar 26. |
| 34215841 | Background | Finkle JD, Boulos H, Driessen TM, Lo C, Blidner RA, Hafez A, Khan AA, Lozac'hmeur A, McKinnon KE, Perera J, Zhu W, Dowlati A, White KP, Tell R, Beaubier N. Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA. NPJ Precis Oncol. 2021 Jul 2;5(1):63. doi: 10.1038/s41698-021-00202-2. |
| 34570988 | Background | Malapelle U, Pisapia P, Addeo A, Arrieta O, Bellosillo B, Cardona AF, Cristofanilli M, De Miguel-Perez D, Denninghoff V, Duran I, Jantus-Lewintre E, Nuzzo PV, O'Byrne K, Pauwels P, Pickering EM, Raez LE, Russo A, Serrano MJ, Gandara DR, Troncone G, Rolfo C. Liquid biopsy from research to clinical practice: focus on non-small cell lung cancer. Expert Rev Mol Diagn. 2021 Nov;21(11):1165-1178. doi: 10.1080/14737159.2021.1985468. Epub 2021 Oct 11. |
| Public Procurement of Innovation: Liquiq Biopsy | View source |
| Andalusian Health System | View source |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |