Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT04163159
Status:
UNKNOWN
Last Update Posted:
2019-11-25
First Post:
2019-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and whole blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of circulating free DNA (cfDNA) concentration (in ng/uL) obtained from peripheral blood (liquid biopsy).', 'timeFrame': '12 months', 'description': 'Samples will be analyze with Real time PCR and fluorometric assay and compare with overall survival'}, {'measure': 'Number of somatic mutation findings in circulating free DNA (cfDNA) obtained from peripheral blood (liquid biopsy)', 'timeFrame': '12 months', 'description': 'Samples will be analyze with targeted NGS sequencing panel'}], 'secondaryOutcomes': [{'measure': 'Estrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor 2 (HER2) status', 'timeFrame': '24 months', 'description': 'ER, PR, HER2 status'}, {'measure': 'Overall survival of participant', 'timeFrame': '24 months', 'description': 'Overall survival of participant'}, {'measure': 'Cancer stage of participant', 'timeFrame': '24 months', 'description': 'Cancer stage of participant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer', 'Mutation, Point']}, 'referencesModule': {'references': [{'pmid': '15317891', 'type': 'BACKGROUND', 'citation': 'Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.'}, {'pmid': '23484797', 'type': 'BACKGROUND', 'citation': 'Dawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.'}, {'pmid': '24449238', 'type': 'BACKGROUND', 'citation': 'Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21.'}, {'pmid': '28330468', 'type': 'BACKGROUND', 'citation': 'Garcia-Saenz JA, Ayllon P, Laig M, Acosta-Eyzaguirre D, Garcia-Esquinas M, Montes M, Sanz J, Barquin M, Moreno F, Garcia-Barberan V, Diaz-Rubio E, Caldes T, Romero A. Tumor burden monitoring using cell-free tumor DNA could be limited by tumor heterogeneity in advanced breast cancer and should be evaluated together with radiographic imaging. BMC Cancer. 2017 Mar 22;17(1):210. doi: 10.1186/s12885-017-3185-9.'}, {'pmid': '23628188', 'type': 'BACKGROUND', 'citation': 'Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldana K, Ferreyra M, Debiasi M, Liedke PE, Touya D, Werutsky G, Higgins M, Fan L, Vasconcelos C, Cazap E, Vallejos C, Mohar A, Knaul F, Arreola H, Batura R, Luciani S, Sullivan R, Finkelstein D, Simon S, Barrios C, Kightlinger R, Gelrud A, Bychkovsky V, Lopes G, Stefani S, Blaya M, Souza FH, Santos FS, Kaemmerer A, de Azambuja E, Zorilla AF, Murillo R, Jeronimo J, Tsu V, Carvalho A, Gil CF, Sternberg C, Duenas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabus R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernandez A, Bertolino M, Schwartsmann G, Santillana S, Esteva F, Fein L, Mano M, Gomez H, Hurlbert M, Durstine A, Azenha G. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013 Apr;14(5):391-436. doi: 10.1016/S1470-2045(13)70048-2.'}, {'pmid': '23129736', 'type': 'BACKGROUND', 'citation': 'Overman MJ, Modak J, Kopetz S, Murthy R, Yao JC, Hicks ME, Abbruzzese JL, Tam AL. Use of research biopsies in clinical trials: are risks and benefits adequately discussed? J Clin Oncol. 2013 Jan 1;31(1):17-22. doi: 10.1200/JCO.2012.43.1718. Epub 2012 Nov 5.'}, {'pmid': '26389210', 'type': 'BACKGROUND', 'citation': 'PDQ Cancer Genetics Editorial Board. Genetics of Breast and Gynecologic Cancers (PDQ(R)): Health Professional Version. 2025 Mar 6. In: PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. Available from http://www.ncbi.nlm.nih.gov/books/NBK65767/'}, {'pmid': '27993161', 'type': 'BACKGROUND', 'citation': 'Uehiro N, Sato F, Pu F, Tanaka S, Kawashima M, Kawaguchi K, Sugimoto M, Saji S, Toi M. Circulating cell-free DNA-based epigenetic assay can detect early breast cancer. Breast Cancer Res. 2016 Dec 19;18(1):129. doi: 10.1186/s13058-016-0788-z.'}, {'pmid': '28283903', 'type': 'BACKGROUND', 'citation': 'Yanagawa T, Kagara N, Miyake T, Tanei T, Naoi Y, Shimoda M, Shimazu K, Kim SJ, Noguchi S. Detection of ESR1 mutations in plasma and tumors from metastatic breast cancer patients using next-generation sequencing. Breast Cancer Res Treat. 2017 Jun;163(2):231-240. doi: 10.1007/s10549-017-4190-z. Epub 2017 Mar 10.'}, {'pmid': '28229982', 'type': 'BACKGROUND', 'citation': 'Ye Q, Qi F, Bian L, Zhang SH, Wang T, Jiang ZF. Circulating-free DNA Mutation Associated with Response of Targeted Therapy in Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer. Chin Med J (Engl). 2017 Mar 5;130(5):522-529. doi: 10.4103/0366-6999.200542.'}]}, 'descriptionModule': {'briefSummary': 'The use of circulating tumor DNA (ctDNA) as a noninvasive test for breast cancer monitoring throughout the course of the disease', 'detailedDescription': 'The concentrations of the cell free DNA (cfDNA) and somatic mutations in circulating tumor DNA (ctDNA) in serial samples correlate with the number of days of the progression-free period and with the overall survival.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Metastasic breast cancer females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic breast cancer before the start of chemotherapeutic treatment\n\nExclusion Criteria:\n\n* Patients with incomplete clinical records'}, 'identificationModule': {'nctId': 'NCT04163159', 'briefTitle': 'Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer Patients in Costa Rica', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Costa Rica'}, 'officialTitle': 'Genetic Markers of Circulating Tumor DNA for Monitoring Breast Cancer in Patients of the Hospital San Juan de Dios From 2018 to 2020.', 'orgStudyIdInfo': {'id': 'R018-SABI-00193'}, 'secondaryIdInfos': [{'id': 'B9316', 'type': 'OTHER', 'domain': 'Universidad de Costa Rica'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'San José', 'status': 'RECRUITING', 'country': 'Costa Rica', 'contacts': [{'name': 'Allan E Ramos-Esquivel, MD, MSc', 'role': 'CONTACT', 'email': 'allan.ramos@ucr.ac.cr', 'phone': '+50688448187'}], 'facility': 'Hospital San Juan de Dios', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}], 'centralContacts': [{'name': 'Ricardo Chinchilla', 'role': 'CONTACT', 'email': 'ricardo.chinchilla_m@ucr.ac.cr', 'phone': '+50625113483'}, {'name': 'Allan Ramos, Msc.', 'role': 'CONTACT', 'email': 'allan.ramos@ucr.ac.cr', 'phone': '+50688448187'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Costa Rica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}