Clinical trial · Observational
Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer
NCT05379907CI-TRIAL-00069342withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Determined that the tumor analysis could not be performed in accordance with the protocol.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIGNATERA™ ctDNA testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Impact of SIGNATERA™ on treatment decisions
- timeFrame
- 2 years
- description
- Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires
Secondary outcomes (4)
- measure
- Frequency of positive SIGNATERA™ ctDNA testing
- timeFrame
- 2 years
- description
- Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection
- measure
- Overall survival of patients managed with SIGNATERA™ ctDNA data
- timeFrame
- 2 years
- description
- Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDGBD 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
- BACKGROUNDSiegel 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
- BACKGROUNDVaradhachary 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
- BACKGROUNDSpitz 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
- BACKGROUNDPhilip 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
- RESULTReinert 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.