NCT06043921Recruiting
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Source: ClinicalTrials.gov · Last updated 21 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 6 Sept 2023
- Start date
- 1 Nov 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Invitae Corporation
- Diseases
- Pancreatic cancer
- NCT number
- NCT06043921
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Nov 2022 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Common exclusion criteria for both the unresectable and resectable pancreatic cancer patient cohorts:
- Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 2 years or shorter.
Other
- Women who are pregnant or planning to become pregnant.
- Judged by the investigator as being unsuitable for participation in the study.
Who the study is looking for
- Unresectable Pancreatic Cancer:
- At least 20 years of age at the time of consent
- 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)
- Scheduled to receive systemic chemotherapy for unresectable pancreatic cancer.
- No prior treatment for pancreatic cancer
- Willing to provide blood and tissue samples in accordance with the research protocol.
- Adequate tissue samples are available
- Written informed consent for participating in this study
- Resectable Pancreatic Cancer:
- At least 20 years of age at the time of consent.
- Tissue sample collected by EUS-FNA/FNB and histopathologically diagnosed as having adenocarcinoma.
- Diagnosed as having cancer meet any one of a to d below within 60 days prior to enrollment
- cStage IA (T1 N0 M0)
- cStage IB (T2 N0 M0)
- cStage IIA (T3 N0 M0)
- cStage IIB (T1-3 N1 M0)
- Scheduled to undergo surgery for resectable pancreatic cancer.
- No history of prior treatment for pancreatic cancer.
- Willing to submit blood and tissue samples in accordance with the research protocol.
- Adequate tissue samples are available
- Written informed consent for participating in this study
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.