Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel

NCT06043921 | Recruiting

• 1 other identifier: 2021-003
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

Circulating tumor DNA; Molecular Residual Disease; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Cohort of patients with unresectable pancreatic cancer; Pretreatment ctDNA detection rate for each disease stage (stage III and stage IV)

  3 years

• Cohort of patients with unresectable pancreatic cancer; Association of pretreatment ctDNA detection rate and the treatment efficacy

  3 years

• Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CA19-9) and treatment efficacy

  3 years

• Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CEA) and treatment efficacy

  3 years

• Cohort of patients with unresectable pancreatic cancer; Association of ctDNA levels and treatment efficacy

  3 years

Study Arms (2)

Unresectable Pancreatic Cancer

Other: No intervention

Resectable Pancreatic Cancer

Other: No intervention

Interventions

No intervention OTHER

There is no intervention associated with this observational study.

Resectable Pancreatic Cancer; Unresectable Pancreatic Cancer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with resectable and unresectable Pancreatic Cancer

You may qualify if:

• A. 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
• B. 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)

You may not qualify if:

• Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 2 years or shorter.
• Women who are pregnant or planning to become pregnant.
• Judged by the investigator as being unsuitable for participation in the study.

Sponsors & Collaborators

• Invitae Corporation: lead
• National Cancer Center Hospital East: collaborator

Study Sites (1)

National Cancer Center Hospital East

Kashiwa, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patients who have been diagnosed with pancreatic cancer and who have formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole-blood samples for the initial testing. Blood samples will be collected for additional ctDNA monitoring samples using the Invitae Personalized Cancer MonitoringTM test. Blood samples will be stored at Invitae MetroPark and may be used for future research.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Taro Shibuki, MD

  Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taro Shibuki, MD

CONTACT

+81-4-7133-1111; tshibuki@east.ncc.go.jp

Lee Ifhar (sponsor contact)

CONTACT

lee.ifhar@invitae.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

JP (1)