Clinical trial NCT05379907: Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
Official title: Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Cancer
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Natera, Inc.
First posted: 2022-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants with Resectable and Borderline Resectable Pancreatic Cancer

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.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines
3. No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
4. ECOG performance status ≤ 1
5. Clinically eligible for chemotherapy
6. Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
7. Has residual FFPE specimen available for submission to Natera
8. Able to read, understand and provide written informed consent
9. Willing and able to comply with the study requirements

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Radiologic evidence of distant metastases
3. Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
4. Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer
5. Neuropathy \> grade 2
6. History of bone marrow or organ transplant
7. Blood transfusion within 1 month of enrollment
8. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
9. Serious medical condition that may adversely affect ability to participate in the study

Primary outcomes:
measure: Impact of SIGNATERA™ on treatment decisions
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of positive SIGNATERA™ ctDNA testing
timeFrame: 2 years
measure: Overall survival of patients managed with SIGNATERA™ ctDNA data
timeFrame: 2 years
measure: Progression-free survival of patients managed with SIGNATERA™ ctDNA data
timeFrame: 2 years
measure: Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations
timeFrame: 2 years
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: Inova Schar Cancer Institute
name: Raymond Wadlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528.
citation: Dasari A, Morris VK, Allegra CJ, Atreya C, Benson AB 3rd, Boland P, Chung K, Copur MS, Corcoran RB, Deming DA, Dwyer A, Diehn M, Eng C, George TJ, Gollub MJ, Goodwin RA, Hamilton SR, Hechtman JF, Hochster H, Hong TS, Innocenti F, Iqbal A, Jacobs SA, Kennecke HF, Lee JJ, Lieu CH, Lenz HJ, Lindwasser OW, Montagut C, Odisio B, Ou FS, Porter L, Raghav K, Schrag D, Scott AJ, Shi Q, Strickler JH, Venook A, Yaeger R, Yothers G, You YN, Zell JA, Kopetz S. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020 Dec;17(12):757-770. doi: 10.1038/s41571-020-0392-0. Epub 2020 Jul 6.