NCT06043921 Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
| NCT ID | NCT06043921 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Invitae Corporation |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-11-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: A. Unresectable Pancreatic Cancer: 1. At least 20 years of age at the time of consent 2. Histopathologically confirmed adenocarcinoma and diagnosed as having ① or ② described below within 60 days prior to enrollment * Clinical Stage Ⅲ (T1-3N2M0, T4 anyNM0) * Clinical Stage Ⅳ (anyTanyNM1) 3. Scheduled to receive systemic chemotherapy for unresectable pancreatic cancer. 4. No prior treatment for pancreatic cancer 5. Willing to provide blood and tissue samples in accordance with the research protocol. 6. Adequate tissue samples are available 7. Written informed consent for participating in this study B. Resectable Pancreatic Cancer: 1. At least 20 years of age at the time of consent. 2. Tissue sample collected by EUS-FNA/FNB and histopathologically diagnosed as having adenocarcinoma. 3. Diagnosed as having cancer meet any one of a to d below within 60 days prior to enrollment 1. cStage IA (T1 N0 M0) 2. cStage IB (T2 N0 M0) 3. cStage IIA (T3 N0 M0) 4. cStage IIB (T1-3 N1 M0) 4. Scheduled to undergo surgery for resectable pancreatic cancer. 5. No history of prior treatment for pancreatic cancer. 6. Willing to submit blood and tissue samples in accordance with the research protocol. 7. Adequate tissue samples are available 8. Written informed consent for participating in this study Exclusion Criteria: Common exclusion criteria for both the unresectable and resectable pancreatic cancer patient cohorts: 1. Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 2 years or shorter. 2. Women who are pregnant or planning to become pregnant. 3. Judged by the investigator as being unsuitable for participation in the study.
Contact & Investigator
Taro Shibuki, MD
PRINCIPAL INVESTIGATOR
Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan
Frequently Asked Questions
Who can join the NCT06043921 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06043921 currently recruiting?
Yes, NCT06043921 is actively recruiting participants. Contact the research team at tshibuki@east.ncc.go.jp for enrollment information.
Where is the NCT06043921 trial being conducted?
This trial is being conducted at Kashiwa, Japan.
Who is sponsoring the NCT06043921 clinical trial?
NCT06043921 is sponsored by Invitae Corporation. The principal investigator is Taro Shibuki, MD at Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan. The trial plans to enroll 150 participants.
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