Evaluating blood tests for monitoring pancreatic cancer
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
This study is testing a new blood test to see if it can help monitor pancreatic cancer by checking for signs of cancer DNA in patients during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Invitae Corporation Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kashiwa) |
| Trial ID | NCT06043921 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational study aims to assess the effectiveness of the Invitae Personalized Cancer MonitoringTM assay in patients with both resectable and unresectable pancreatic cancer. Participants will have blood samples collected at various time points during their treatment to monitor circulating tumor DNA (ctDNA), which can indicate the presence of molecular residual disease (MRD). The study will involve 150 patients, with specific protocols for blood sampling and imaging based on their cancer stage and treatment type. The primary focus is on developing personalized blood tests using tumor tissue and evaluating the concordance of KRAS mutations between tumor tissue and blood samples.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with histopathologically confirmed adenocarcinoma of the pancreas, either resectable or unresectable, who have not received prior treatment.
Not a fit: Patients with prior treatment for pancreatic cancer or those with other types of cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of pancreatic cancer treatment and better detection of residual disease.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kashiwa
- National Cancer Center Hospital East — Kashiwa, Japan (Recruiting)
Study contacts
- Principal investigator: Taro Shibuki, MD — Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan
- Study coordinator: Taro Shibuki, MD
- Email: tshibuki@east.ncc.go.jp
- Phone: +81-4-7133-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.