Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Impact of SIGNATERA™ on treatment decisions [2 years]
Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires
Secondary Outcome Measures
- Frequency of positive SIGNATERA™ ctDNA testing [2 years]
Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection
- Overall survival of patients managed with SIGNATERA™ ctDNA data [2 years]
Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls
- Progression-free survival of patients managed with SIGNATERA™ ctDNA data [2 years]
Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls
- Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations [2 years]
Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
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No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
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ECOG performance status ≤ 1
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Clinically eligible for chemotherapy
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Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
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Has residual FFPE specimen available for submission to Natera
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Able to read, understand and provide written informed consent
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Willing and able to comply with the study requirements
Exclusion Criteria:
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Pregnant or breastfeeding
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Radiologic evidence of distant metastases
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Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
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Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
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Neuropathy > grade 2
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History of bone marrow or organ transplant
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Blood transfusion within 1 month of enrollment
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Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
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Serious medical condition that may adversely affect ability to participate in the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Inova Health Care Services
- Natera, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- GBD 2017 Pancreatic Cancer Collaborators. The global, regional, and national burden of pancreatic cancer and its attributable risk factors in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):934-947. doi: 10.1016/S2468-1253(19)30347-4. Epub 2019 Oct 21. Erratum in: Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2.
- Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.
- Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum in: CA Cancer J Clin. 2021 Jul;71(4):359.
- Spitz FR, Abbruzzese JL, Lee JE, Pisters PW, Lowy AM, Fenoglio CJ, Cleary KR, Janjan NA, Goswitz MS, Rich TA, Evans DB. Preoperative and postoperative chemoradiation strategies in patients treated with pancreaticoduodenectomy for adenocarcinoma of the pancreas. J Clin Oncol. 1997 Mar;15(3):928-37. Review.
- Varadhachary GR, Tamm EP, Abbruzzese JL, Xiong HQ, Crane CH, Wang H, Lee JE, Pisters PW, Evans DB, Wolff RA. Borderline resectable pancreatic cancer: definitions, management, and role of preoperative therapy. Ann Surg Oncol. 2006 Aug;13(8):1035-46. Epub 2006 Jul 24. Review.
- U22-02-4671