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2022-11-01
2026-12
2026-12
150
NCT06043921
Invitae Corporation
Invitae Corporation
OBSERVATIONAL
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
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.
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-FNA/FNB, 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-09-06 | N/A | 2023-09-12 |
2023-09-12 | N/A | 2023-09-21 |
2023-09-21 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Unresectable Pancreatic Cancer | OTHER: No intervention
|
| : Resectable Pancreatic Cancer | OTHER: No intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Cohort of patients with unresectable pancreatic cancer; Rate of concordance of KRAS mutations between tumor tissue and blood samples Primary endpoint | Compare the presence or absence of KRAS mutations in the tumor tissue to the presence or absence of KRAS mutations in the blood for cases in which KRAS is included in the patient specific panel | 3 years |
| Cohort of patients with resectable pancreatic cancer; Success rate of WES assays and selections of personalized genes using tumor tissue specimens obtained by EUS-FNA/FNB | Calculate the proportion of patients with resectable pancreatic cancer who are able to successfully have a custom ctDNA panel created with the EUS-FNA/FNB tissue provided | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Cohort of patients with unresectable pancreatic cancer; Pretreatment ctDNA detection rate for each disease stage (stage III and stage IV) | Calculate the proportion of patients with stage III and stage IV with a positive Invitae Personalized Cancer Monitoring test prior to receiving any treatment. | 3 years |
| Cohort of patients with unresectable pancreatic cancer; Association of pretreatment ctDNA detection rate and the treatment efficacy | Compare the proportion of patients who have a positive versus negative Invitae Personalized Cancer Monitoring test prior to treatment with treatment efficacy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria after the start of 1st line chemotherapy. | 3 years |
| Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CA19-9) and treatment efficacy | Compare CA19-9 levels in the blood as measured by units per millimeter (u/mL) prior to receiving any treatment to treatment efficacy as measured by RECIST criteria | 3 years |
| Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CEA) and treatment efficacy | Compare CEA levels in the blood as measured by nanograms per milliliter of blood (ng/mL) prior to receiving any treatment to treatment efficacy as measured by RECIST criteria | 3 years |
| Cohort of patients with unresectable pancreatic cancer; Association of ctDNA levels and treatment efficacy | Compare ctDNA levels as measured by ctDNA fraction in the Invitae Personalized Cancer Monitoring test prior to receiving any treatment to treatment efficacy as measured by RECIST criteria | 3 years |
| Cohort of patients with resectable pancreatic cancer; Rate of ctDNA positivity for each cancer stage (stage IA-stage IIB) before neoadjuvant chemotherapy (NAC) and 4 weeks after surgery | Calculate the proportion of patients by each cancer stage (IA-stage IIB) with a positive Invitae Personalized Cancer MonitoringTM test before the start of neoadjuvant therapy and at the blood draw 4 weeks after surgery. | 3 years |
| Cohort of patients with resectable pancreatic cancer; Association of preoperative ctDNA before NAC and overall survival | Compare overall survival between patients who have a positive versus negative Invitae Personalized Cancer MonitoringTM test prior to neoadjuvant treatment | 3 years |
| Cohort of patients with resectable pancreatic cancer; Association of postoperative ctDNA before adjuvant chemotherapy (AC) and overall survival | Compare overall survival between patients who have a positive versus negative Invitae Personalized Cancer MonitoringTM test after surgery | 3 years |
| Cohort of patients with resectable pancreatic cancer; Proportion of ctDNA positivity at the time of recurrence detected by diagnostic imaging | Calculate the proportion of patients with a positive Invitae Personalized Cancer Monitoring test at the time of clinical recurrence as detected by imaging scans | 3 years |
| Cohort of patients with resectable pancreatic cancer, Association of CA-19-9 levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival | Compare CA19-9 levels as measured by units per millimeter (u/mL) before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival | 3 years |
| Cohort of patients with resectable pancreatic cancer, association of CEA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival | Compare CEA levels as measured by nanograms per milliliter of blood (ng/mL) before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival | 3 years |
| Cohort of patients with resectable pancreatic cancer, association of ctDNA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival | Compare ctDNA levels as measured by ctDNA fraction in the Invitae Personalized Cancer Monitoring test before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival | 3 years |
| Cohort of patients with resectable pancreatic cancer; Differences in OS and PFS between the patients in whom the personalized panel can be created and those in whom it cannot be created | Compare the ability to generate a personalized ctDNA panel with disease free and overall survival | 3 years |
| Cohort of patients with resectable pancreatic cancer; to investigate the lead time of ctDNA detection of recurrence before detection of recurrence via imaging methods | Calculate the lead time as measured by months between a positive Invitae Personalized Cancer Monitoring test and positive imaging findings by either CT or MRI | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Taro Shibuki, MD Phone Number: +81-4-7133-1111 Email: tshibuki@east.ncc.go.jp |
Study Contact Backup Name: Lee Ifhar (sponsor contact) Phone Number: Email: lee.ifhar@invitae.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
