Clinical trial NCT06043921: Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Official title: Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Keywords: Circulating tumor DNA
Molecular Residual Disease
Pancreatic Cancer
Lead sponsor: Invitae Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Center Hospital East
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with resectable and unresectable Pancreatic Cancer

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Cohort of patients with unresectable pancreatic cancer; Rate of concordance of KRAS mutations between tumor tissue and blood samples Primary endpoint
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: Cohort of patients with unresectable pancreatic cancer; Pretreatment ctDNA detection rate for each disease stage (stage III and stage IV)
timeFrame: 3 years
measure: Cohort of patients with unresectable pancreatic cancer; Association of pretreatment ctDNA detection rate and the treatment efficacy
timeFrame: 3 years
measure: Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CA19-9) and treatment efficacy
timeFrame: 3 years
measure: Cohort of patients with unresectable pancreatic cancer; Association of pretreatment serum marker levels (CEA) and treatment efficacy
timeFrame: 3 years
measure: Cohort of patients with unresectable pancreatic cancer; Association of ctDNA levels and treatment efficacy
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer; Association of preoperative ctDNA before NAC and overall survival
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer; Association of postoperative ctDNA before adjuvant chemotherapy (AC) and overall survival
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer; Proportion of ctDNA positivity at the time of recurrence detected by diagnostic imaging
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer, Association of CA-19-9 levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer, association of CEA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer, association of ctDNA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: Cohort of patients with resectable pancreatic cancer; to investigate the lead time of ctDNA detection of recurrence before detection of recurrence via imaging methods
timeFrame: 3 years
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
Study officials:
affiliation: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan
name: Taro Shibuki, MD
role: PRINCIPAL_INVESTIGATOR
References: