Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05379907
• Other study ID #: U22-02-4671
• Status: Withdrawn
• Start date: August 23, 2022
• Est. completion date: August 23, 2023

Study information

• Verified date: September 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	Natera, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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, Kenne — View Citation

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. — View Citation

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. — View 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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of SIGNATERA™ on treatment decisions	Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires	2 years
Secondary	Frequency of positive SIGNATERA™ ctDNA testing	Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection	2 years
Secondary	Overall survival of patients managed with SIGNATERA™ ctDNA data	Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls	2 years
Secondary	Progression-free survival of patients managed with SIGNATERA™ ctDNA data	Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls	2 years
Secondary	Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations	Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires	2 years