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Pancreatic CancerARTEMIS-PCNCT06043921

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

An observational study of Pancreatic Cancer, run by Invitae Corporation at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pancreatic Cancer
How many people
150 participants
Where
1 siteJapan
Study dates
1 Nov 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with resectable and unresectable Pancreatic Cancer

Who may be able to join

  • 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.
Show all 23Show fewer
  • 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

Who cannot join

  • 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.
  • Women who are pregnant or planning to become pregnant.
  • Judged by the investigator as being unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taro Shibuki, MD contact

+81-4-7133-1111

tshibuki@east.ncc.go.jp

Lee Ifhar (sponsor contact) contact

lee.ifhar@invitae.com

Japan1 site, 1 recruiting

  • National Cancer Center Hospital East

    Kashiwa

    Taro Shibuki, MD, +81-4-7133-1111, tshibuki@east.ncc.go.jp

    Recruiting

Other trials in Japan

About this study

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.

Read the 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.

Being tested
No intervention
Keywords
Circulating tumor DNA, Molecular Residual Disease, Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There is no intervention associated with this observational study.

Study groups in NCT06043921
Study groupRoleWhat they receive
Unresectable Pancreatic CancerNot described
Receives: Other: No intervention
Resectable Pancreatic CancerNot described
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 years

  2. 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

    Measured: 3 years

Secondary outcomes (14)

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

    Calculate the proportion of patients with stage III and stage IV with a positive Invitae Personalized Cancer Monitoring test prior to receiving any treatment.

    Measured: 3 years

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

    Compare the proportion of patients who have a positive versus negative Invitae Personalized Cancer Monitoring test prior to treatment with treatment efficacy as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria after the start of 1st line chemotherapy.

    Measured: 3 years

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

    Compare CA19-9 levels in the blood as measured by units per millimeter (u/mL) prior to receiving any treatment to treatment efficacy as measured by RECIST criteria

    Measured: 3 years

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

    Compare CEA levels in the blood as measured by nanograms per milliliter of blood (ng/mL) prior to receiving any treatment to treatment efficacy as measured by RECIST criteria

    Measured: 3 years

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

    Compare ctDNA levels as measured by ctDNA fraction in the Invitae Personalized Cancer Monitoring test prior to receiving any treatment to treatment efficacy as measured by RECIST criteria

    Measured: 3 years

  6. 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

    Calculate the proportion of patients by each cancer stage (IA-stage IIB) with a positive Invitae Personalized Cancer MonitoringTM test before the start of neoadjuvant therapy and at the blood draw 4 weeks after surgery.

    Measured: 3 years

  7. Cohort of patients with resectable pancreatic cancer; Association of preoperative ctDNA before NAC and overall survival

    Compare overall survival between patients who have a positive versus negative Invitae Personalized Cancer MonitoringTM test prior to neoadjuvant treatment

    Measured: 3 years

  8. Cohort of patients with resectable pancreatic cancer; Association of postoperative ctDNA before adjuvant chemotherapy (AC) and overall survival

    Compare overall survival between patients who have a positive versus negative Invitae Personalized Cancer MonitoringTM test after surgery

    Measured: 3 years

  9. Cohort of patients with resectable pancreatic cancer; Proportion of ctDNA positivity at the time of recurrence detected by diagnostic imaging

    Calculate the proportion of patients with a positive Invitae Personalized Cancer Monitoring test at the time of clinical recurrence as detected by imaging scans

    Measured: 3 years

  10. Cohort of patients with resectable pancreatic cancer, Association of CA-19-9 levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival

    Compare CA19-9 levels as measured by units per millimeter (u/mL) before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival

    Measured: 3 years

  11. Cohort of patients with resectable pancreatic cancer, association of CEA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival

    Compare CEA levels as measured by nanograms per milliliter of blood (ng/mL) before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival

    Measured: 3 years

  12. Cohort of patients with resectable pancreatic cancer, association of ctDNA levels before neoadjuvant chemotherapy and before adjuvant chemotherapy with recurrence free survival

    Compare ctDNA levels as measured by ctDNA fraction in the Invitae Personalized Cancer Monitoring test before neoadjuvant chemotherapy and before adjuvant chemotherapy to recurrence free survival

    Measured: 3 years

  13. 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

    Compare the ability to generate a personalized ctDNA panel with disease free and overall survival

    Measured: 3 years

  14. Cohort of patients with resectable pancreatic cancer; to investigate the lead time of ctDNA detection of recurrence before detection of recurrence via imaging methods

    Calculate the lead time as measured by months between a positive Invitae Personalized Cancer Monitoring test and positive imaging findings by either CT or MRI

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start1 Nov 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06043921
Sponsor's protocol ID
2021-003
Acronym
ARTEMIS-PC
Status last verified
Sep 2023
First submitted
6 Sep 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cancer, run by Invitae Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Taro Shibuki, MD (+81-4-7133-1111, tshibuki@east.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort of patients with unresectable pancreatic cancer; Rate of concordance of KRAS mutations between tumor tissue and blood samples Primary endpoint (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06043921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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