Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform
Background: Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically re...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865425000201 |
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| author | Alexia Exarchos Ariel B. Bourla Maneet Kaur Katja Schulze Sophia Maund Yi Cao Yihua Zhao Elizabeth H. Williams Sarah C. Gaffey Richard Zuniga Shaily Lakhanpal Vladan Antic Michelle Doral Johanna Sy Neal J. Meropol Anne C. Chiang |
| author_facet | Alexia Exarchos Ariel B. Bourla Maneet Kaur Katja Schulze Sophia Maund Yi Cao Yihua Zhao Elizabeth H. Williams Sarah C. Gaffey Richard Zuniga Shaily Lakhanpal Vladan Antic Michelle Doral Johanna Sy Neal J. Meropol Anne C. Chiang |
| author_sort | Alexia Exarchos |
| collection | DOAJ |
| description | Background: Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing. Methods: Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling. Results: Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants. Conclusion: A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation. |
| format | Article |
| id | doaj-art-3efe58e242034bfeb26b050793ec0944 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-3efe58e242034bfeb26b050793ec09442025-02-12T05:31:28ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-0144101446Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platformAlexia Exarchos0Ariel B. Bourla1Maneet Kaur2Katja Schulze3Sophia Maund4Yi Cao5Yihua Zhao6Elizabeth H. Williams7Sarah C. Gaffey8Richard Zuniga9Shaily Lakhanpal10Vladan Antic11Michelle Doral12Johanna Sy13Neal J. Meropol14Anne C. Chiang15Genentech, Inc., South San Francisco, CA, USA; Corresponding author. Genentech, Inc. 1 DNA Way South San Francisco, CA, 94080, USA.Flatiron Health, Inc., New York, NY, USAFlatiron Health, Inc., New York, NY, USAGenentech, Inc., South San Francisco, CA, USAGenentech, Inc., South San Francisco, CA, USAGenentech, Inc., South San Francisco, CA, USAFlatiron Health, Inc., New York, NY, USAFoundation Medicine, Inc., Cambridge, MA, USAFoundation Medicine, Inc., Cambridge, MA, USANew York Cancer & Blood Specialists, New York, NY, USAAlabama Oncology, Birmingham, AL, USAF. Hoffmann-La Roche Ltd, Basel, SwitzerlandGenentech, Inc., South San Francisco, CA, USAGenentech, Inc., South San Francisco, CA, USAFlatiron Health, Inc., New York, NY, USAYale School of Medicine, New Haven, CT, USABackground: Discovery and incorporation of predictive and prognostic biomarkers enhance outcomes for patients with cancer. Clinico-genomic datasets, which retrospectively link real-world clinical data to tumor sequencing data, are important resources for biomarker research, which has historically relied on robust research infrastructures exclusive to large academic centers. The objective was to evaluate the feasibility of a pragmatic, technology-enabled platform at community-based research sites for development of a prospective clinico-genomic database supported by centralized electronic health record (EHR)–based patient ascertainment and data processing. Methods: Adults with stage IV or recurrent metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer were enrolled at 23 US sites upon initiating a standard line of therapy. Enrollment rates were estimated from eligible populations at individual centers. Clinical data from routinely collected EHR documentation were centrally processed and normalized for quality control. Serial blood samples at pre-specified timepoints (baseline, during treatment and at disease progression/end of therapy) were used for circulating tumor DNA (ctDNA) genomic profiling. Results: Between December 2019 and May 2021, 944 patients enrolled, representing ≈25 % of eligible patients. Eight-hundred seventeen of 944 (87 %), 406 of 606 (67 %) and 398 of 852 (47 %) participants provided qualifying samples for ctDNA testing at baseline, during treatment and at disease progression/end of therapy, respectively. Samples were provided at all three timepoints by 35 % of participants. Conclusion: A community-based oncology patient cohort was rapidly enrolled, creating a real-world clinico-genomic dataset. This pragmatic study platform has potential research applications where prospective real-world data may contribute to evidence generation.http://www.sciencedirect.com/science/article/pii/S2451865425000201Prospective studyCirculating tumor DNAFeasibility studyElectronic health recordsLung neoplasms |
| spellingShingle | Alexia Exarchos Ariel B. Bourla Maneet Kaur Katja Schulze Sophia Maund Yi Cao Yihua Zhao Elizabeth H. Williams Sarah C. Gaffey Richard Zuniga Shaily Lakhanpal Vladan Antic Michelle Doral Johanna Sy Neal J. Meropol Anne C. Chiang Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform Contemporary Clinical Trials Communications Prospective study Circulating tumor DNA Feasibility study Electronic health records Lung neoplasms |
| title | Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform |
| title_full | Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform |
| title_fullStr | Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform |
| title_full_unstemmed | Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform |
| title_short | Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform |
| title_sort | real world enrollment for a prospective clinico genomic database using a pragmatic technology enabled platform |
| topic | Prospective study Circulating tumor DNA Feasibility study Electronic health records Lung neoplasms |
| url | http://www.sciencedirect.com/science/article/pii/S2451865425000201 |
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