Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06043921
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-09-06
Brief Title:
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Sponsor:
Invitae Corporation
Organization:
Invitae Corporation
Study Overview
Official Title:
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Status:
RECRUITING
Status Verified Date:
2023-09
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:
ARTEMIS-PC
Brief Summary:
This is a multicenter prospective observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer Using tumor tissue a personalized blood test the Invitae Personalized Cancer MonitoringTM test will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA ctDNA The presence of residual cancer cells after treatment is known as molecular residual disease MRD and the detection of ctDNA can provide evidence of the presence of MRD Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study
Detailed Description:
This is a multi-site prospective observational trial in Japan of 150 pts with resectable 50 and unresectable 100 PC The main eligibility criteria are histopathologically diagnosed as adenocarcinoma no prior treatment for PC scheduled to undergo surgery for resectable PC or receive systemic therapy for unresectable PC In resectable PC cohort blood samples will be collected before surgery and at 1 3 6 9 12 18 and 24 months after surgery and imaging study will be performed before surgery and at 3 6 9 12 18 and 24 months after surgery In the unresectable PC cohort blood samples will be collected before treatment and at 4 8 12 16 24 32 40 and 48 weeks on treatment and imaging study will be performed before treatment and every 8 weeks on treatment until 48 weeks Primary endpoint in the resectable PC cohort is success rate of creating personalized panel using tumor tissue obtained by EUS-FNAFNB and that in unresectable PC cohort is rate of concordance of KRAS mutations between tumor tissue and blood samples Key secondary endpoints in resectable PC cohort are rate of ctDNA positivity for each cancer stage before neoadjuvant chemotherapy and 4 weeks after surgery and that in unresectable PC cohort is pretreatment ctDNA detection rate for each disease stage
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