Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 6:52 AM
Study NCT ID:
NCT06997458
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-30
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid BiOpsy, Lung and Colon Cancer in AndaluciA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Streck tubes with 8.5mL of blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'Proportion of patients with at least one actionable variant (%)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liquid Biopsy', 'cfDNA', 'ctDNA', 'Metastatic Cancer', 'NGS'], 'conditions': ['Non Small Cell Lung Cancer (NSCLC)', 'Colorectal Cancer (CRC)']}, 'referencesModule': {'references': [{'pmid': '32428812', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38170059', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33781866', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34215841', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '34570988', 'type': 'BACKGROUND', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'https://www.genyo.es/', 'label': 'Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)'}, {'url': 'https://www.liquidbiopsyproject.com/es', 'label': 'Public Procurement of Innovation: Liquiq Biopsy'}, {'url': 'https://www.sspa.juntadeandalucia.es/servicioandaluzdesalud/', 'label': 'Andalusian Health System'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Metastatic adenocarcinoma (NSCLC: 250 and CRC: 250)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral criteria:\n\n* More than 18 years old\n* Both genders\n* Ability to provide written informed consent\n\nSpecific criteria:\n\n* NSCLC\n\n * Patients diagnosed with the 8th Edition of the Tumor, Node, Metastasis (TNM) staging system for Lung Cancer approved by International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)\n * Histologically confirmed NSCLC (adenocarcinoma)\n * Performance status of 0-2 (ECOG PS) ○ Estimated life expectancy ≥3 months\n * Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).\n * Smokers or Non-Smokers\n* CRC\n\n * Patients diagnosed with the Tumor, Node, Metastasis (TNM) staging system for Colorectal Cancer approved by the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)\n * Histologically confirmed CRC (adenocarcinoma)\n * Performance status of 0-2 (ECOG PS)\n * Estimated life expectancy ≥3 months\n * Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).\n\nExclusion Criteria:\n\n* General: History of any other cancer within the previous 5 years, except non-melanoma skin cancer\n* General: Absence of Informed consent. \\> Pregnant or nursing women. \\> Small cell lung cancer.'}, 'identificationModule': {'nctId': 'NCT06997458', 'acronym': 'LOLA-PROJECT', 'briefTitle': 'Liquid BiOpsy, Lung and Colon Cancer in AndaluciA', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental'}, 'officialTitle': 'Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System', 'orgStudyIdInfo': {'id': 'LCI2024-2027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with radiologic evidence of metastatic (stage IV) NSCLC', 'description': '* Patients diagnosed with the 8th Edition of the Tumor, Node, Metastasis (TNM) staging system for Lung Cancer approved by International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c)\n* Histologically confirmed NSCLC (adenocarcinoma)\n* Performance status of 0-2 (ECOG PS)\n* Estimated life expectancy ≥3 months\n* Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).\n* Smokers or Non-Smokers', 'interventionNames': ['Diagnostic Test: xF Tempus assay']}, {'label': 'Patients with radiologic evidence of metastatic (stage IV) CRC', 'description': '* Patients diagnosed with the Tumor, Node, Metastasis (TNM) staging system for Colorectal Cancer approved by the American Joint Committee on Cancer (AJCC): IV (Any T, Any N, M1a-c).\n* Histologically confirmed CRC (adenocarcinoma).\n* Performance status of 0-2 (ECOG PS)\n* Estimated life expectancy ≥3 months\n* Treatment naïve patients (chemotherapy, immunotherapy, targeted therapy, radiotherapy).', 'interventionNames': ['Diagnostic Test: xF Tempus assay']}], 'interventions': [{'name': 'xF Tempus assay', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nThe ctDNA isolation and automatic library preparation will be performed using TEMPUS technology (Finkel et al 2021).\n\nThe 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).', 'armGroupLabels': ['Patients with radiologic evidence of metastatic (stage IV) CRC', 'Patients with radiologic evidence of metastatic (stage IV) NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'M Jose Serrano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO) & University Hospital Virgen de la Nieves'}, {'name': 'Valeria Denninghoff, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre for Genomics and Oncological Research - Pfizer - University of Granada - Andalusian Regional Government (GENyO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tempus AI', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'María José Serrano Fernández', 'investigatorAffiliation': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental'}}}}