Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391892
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-20
Brief Title:
Liquid Biopsy ctDNA Guided Treatment in Localized Pancreatic Cancer Neoadjuvant CTX vs Upfront Surgery
Sponsor:
Elisabethinen Hospital
Organization:
Elisabethinen Hospital
Study Overview
Official Title:
Liquid Biopsy Guided Treatment in Localized Pancreatic Cancer LIQUIPANC Circulating Tumor DNA ctDNA as Precision Medicine Tool for Stratification of Neoadjuvant Chemotherapy vs Upfront Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIQUIPANC
Brief Summary:
This study evaluates the clinical prognostic impact on DFS and OS of liquid biopsy guided treatment vs standard of care physicians choice in localized pancreatic cancer despite because of CA 19-9 levels and computed tomography upfront surgery is recommended by tumor board ctDNA positive patients will receive neoadjvuant chemotherapy at current gold standard physicians choice instead of upfront surgery because of assumed high biological risk for early recurrence
Detailed Description:
Pancreatic cancer PC bears dramatically high relapse rates with consecutive low 5-year survival rates 42 over all tumor stages and 05 in stage IV disease despite major improvements of interdisciplinary perioperative management and more aggressive surgical approaches to enable potentially curative pancreatic surgery PC is estimated to represent the second most cancer associated cause of death by 2030 worldwide Circulating tumor DNA ctDNA has been outpointed to be a promising prognostic marker for several malignant diseases In precursor studies the investigators have shown a a definitive cut-off 42 decrease from the baseline for the relative change of ctDNA after only 2 weeks of systemic chemotherapy to reliably specificity 100 sensitivity 917 predict response to treatment at a median of 10 weeks earlier 80 faster than current gold standard computed tomography after 3 months of treatment via simple blood collection and consecutive molecular analysis via ddPCR Kirchweger et al Frontiers in Oncology 0822 which could allow an early change of treatment regimen in the future in order to improve patients survival and decrease the amount of unevaluated cytotoxic agents Furthermore the investigators could show b that pretherapeutic detectable ctDNA in localized PC could reliably indicate early distant relapse DFS 33 vs 181 months despite no radiological evidence of advanced or disseminated disease prior to surgery Kirchweger et al European Journal of Surgical Oncology 1221 All patients in this study suffering from early relapse went through interdisciplinary tumor boards and did not receive neoadjuvant chemotherapy because of radiological resectability and CA 19-9 values within the normal range 500kUl ctDNA on the other hand bears the potential to differentiate localized from disseminated disease
The planned project aims to prove a clinical applicable easily assessable and minimal invasive approach mere blood collection during clinical routine of molecular testing in the periphery to distinguish localized from disseminated disease in pancreatic cancer patients to highly individually stratify for neoadjuvant chemotherapy or upfront surgery on a molecular-biological base with a high sensitive method to oppose current difficulties of detection rates in PC in addition to current gold standard of radiological staging in the future
The investigators will take approximately 30ml of blood simple blood puncture from patients with localized pancreatic cancer who have undergone full staging procedure and have been recommended upfront surgery by interdisciplinary tumor board ddPCR will be performed by testing KRAS G1213 and if negative KRAS Q61 preoperatively ctDNA positive patients will be distributed to either observation group standard of care - upfront surgery or personalized treatment group LB informed treatment decisions - neoadjuvantadjuvant chemotherapy
Treatment groups will be compared for PFS and OS
The planned project aims to prove a clinical applicable easily assessable and minimal invasive approach mere blood collection during clinical routine of molecular testing in the periphery to distinguish localized from disseminated disease in pancreatic cancer patients to highly individually stratify for neoadjuvant chemotherapy or upfront surgery on a molecular-biological base with a high sensitive method to oppose current difficulties of detection rates in PC in addition to current gold standard of radiological staging in the future
The investigators will take approximately 30ml of blood simple blood puncture from patients with localized pancreatic cancer who have undergone full staging procedure and have been recommended upfront surgery by interdisciplinary tumor board ddPCR will be performed by testing KRAS G1213 and if negative KRAS Q61 preoperatively ctDNA positive patients will be distributed to either observation group standard of care - upfront surgery or personalized treatment group LB informed treatment decisions - neoadjuvantadjuvant chemotherapy
Treatment groups will be compared for PFS and OS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None