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Metastatic Pancreatic CancerNCT07122466

Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

An observational study of Metastatic Pancreatic Cancer, run by Northwell Health at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)
How many people
24 participants
Where
1 siteUnited States
Study dates
22 May 2023to 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The proposed sample size of 20 subjects is based on feasibility and availability of resources and not on a formal power calculation. The number of subjects is small, so as to quickly gather data that could inform a larger study.

Who may be able to join

  • Prior/Concurrent Therapy Criteria
  • Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study
  • Patients must have cytologic or histologic confirmation of pancreatic cancer
  • Patients must have measurable radiographic evidence of metastatic disease
  • Patients must be ≥18 years of age
  • Patients must have an ECOG Performance Status 0-2.
Show all 11Show fewer
  • Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75
  • Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.
  • Regulatory Criteria
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.
  • Patients of all races, genders, \& ethnicities are eligible.

Who cannot join

  • No exclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Zuckerberg Cancer Center

    New Hyde Park, New York, 11042

Other trials in United States

About this study

Official title: Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy in Patients With Advanced Pancreatic Cancer: a Prospective, Observational Pilot Study

This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. To study this question, ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.

Being tested
Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)
Keywords
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.

  • Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)Diagnostic test

    ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.

What is being measured

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

  1. First follow-up imaging assessment

    Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline

    Measured: 2 months

Secondary outcomes (3)

  1. ctDNA Assessment Comparison

    Compare ctDNA assessment at 2 months with earlier ctDNA measurements

    Measured: 2 months

  2. Compare Signatera ctDNA test

    Compare Signatera ctDNA test with another vendor

    Measured: 6 months

  3. ctDNA, CA19-9, & CEA Response

    Compare response of ctDNA with response of CA19-9 and CEA

    Measured: 6 months

Timeline

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

  1. First posted14 Aug 2025
  2. Study start22 May 2023
  3. Primary completion17 Oct 2023
  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
Other
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122466
Sponsor's protocol ID
23-0286
Status last verified
Jun 2026
First submitted
7 Aug 2025
Last updated
26 Jun 2026
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 Metastatic Pancreatic Cancer, run by Northwell Health at 1 site in United States.

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 11 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. 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 United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First follow-up imaging assessment (time frame: 2 months). 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 NCT07122466.

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 26 Jun 2026.

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