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Active, Not Recruiting

NCT Number: NCT07122466

Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zuckerberg Cancer Center

New Hyde Park, New York, 11042, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • 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.

Exclusion criteria

No exclusion criteria.

Treatment and study plan

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.

Primary outcomes

  1. First follow-up imaging assessment

    Time frame: 2 months

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

Secondary outcomes

  1. ctDNA Assessment Comparison

    Time frame: 2 months

    Compare ctDNA assessment at 2 months with earlier ctDNA measurements

  2. Compare Signatera ctDNA test

    Time frame: 6 months

    Compare Signatera ctDNA test with another vendor

  3. ctDNA, CA19-9, & CEA Response

    Time frame: 6 months

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

Other outcomes

  1. Exploratory - Organoid Samples

    Time frame: 2 months

    If organoid samples are available, compare drug response assessment from organoids to clinical response assessment at 2 months.

  2. Exploratory - Sample Size

    Time frame: 6 months

    If sample size has enough power, to compare differences in early ctDNA response between regimens (FOLFIRINOX vs Gemcitabine-based treatment, at 3 days and 1 week, respectively)

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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