Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

NCT05379907 | Withdrawn DMC

• 1 other identifier: U22-02-4671
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Impact of SIGNATERA™ on treatment decisions

  Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires

  2 years

Secondary Outcomes (4)

• Frequency of positive SIGNATERA™ ctDNA testing

  2 years

• Overall survival of patients managed with SIGNATERA™ ctDNA data

  2 years

• Progression-free survival of patients managed with SIGNATERA™ ctDNA data

  2 years

• Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations

  2 years

Interventions

SIGNATERA™ ctDNA testing OTHER

Information collection about how SIGNATERA™ ctDNA testing changes how doctors make treatment recommendations to patients with early-stage pancreatic cancer.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants with Resectable and Borderline Resectable Pancreatic Cancer

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Inova Health Care Services: lead
• Natera, Inc.: collaborator

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Related Publications (7)

• 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.

  PMID: 31648972 BACKGROUND

• 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.

  PMID: 33433946 BACKGROUND

• 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. doi: 10.1245/ASO.2006.08.011. Epub 2006 Jul 24.

  PMID: 16865597 BACKGROUND

• 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. doi: 10.1200/JCO.1997.15.3.928.

  PMID: 9060530 BACKGROUND

• 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, Lopez-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.

  PMID: 31953079 BACKGROUND

• 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.

  PMID: 31070691 RESULT

• 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.

  PMID: 32632268 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Patients who have been diagnosed with R/BR PDAC and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole-blood samples for SIGNATERA™ testing at baseline. Patients will provide additional whole-blood samples for SIGNATERA™ testing at months 1, 2, 4, 6, 9, 12, and 15 from the date of informed consent. The blood samples will be stored at the Inova Schar Cancer Institute and may be shared for future research.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Raymond Wadlow, MD

  Inova Schar Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: August 23, 2022
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)