Pancreas CancerNCT04616131
Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy
An observational study of Pancreas Cancer, run by Northwestern University at 3 sites in United States.
Trial summary
For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2020to 1 Oct 2029
- 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: Male or female individuals age 18 and over planning to receive chemotherapy for pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes.
Who may be able to join
- Biopsy or cytology proven adenocarcinoma of the pancreas
- No clinical evidence of metastatic disease on imaging
- Age 18 or older
- Receiving chemotherapy for non-metastatic pancreatic cancer
Who cannot join
- Biopsy proven metastatic disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Donald Smith, 630-352-5360, Donald.Smith3@nm.org
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60135
Donald Smith, 630-352-5360, donald.smith3@nm.org
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Akhil Chawla, MD, 630-352-5353, Akhil.Chawla@nm.org
About this study
For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.
Read the detailed description
Cancer DNA in the blood stream is called circulating tumor DNA or ctDNA. The presence or absence of pancreatic cancer ctDNA in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. Understanding how treatment alters the ctDNA can help future patients diagnosed with pancreatic cancer. The presence or absence of ctDNA or the clearance of ctDNA after treatment may help to guide further treatment decisions for cancer patients after surgery.
- Conditions
- Pancreas Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
Utilizing Tempus, a commercial laboratory ctDNA genetic profile panel investigators will analyze the number of patients who had detectable ctDNA in their blood prior to neoadjuvant chemotherapy who then had no detectable ctDNA after their chemotherapy treatment.
Measured: 3 months
Secondary outcomes (1)
Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.
Association of ctDNA clearance with the following: pathologic treatment response per CAP tumor regression grade 0,1,2, and 3, blood level measurement of protein CA 19-9 units/milliliter, and radiologic response by tumor measurements in mm and using RECIST tumor measurement categories of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) for all patients, and margin assessment (R0/R1 resection) in resected patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akhil Chawla, MD, Principal investigator, Northwestern Medicine Warrenville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616131
- Sponsor's protocol ID
- NU 20I05 WR
- Status last verified
- Jun 2026
- First submitted
- 21 Oct 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Prognostic Capability of ctDNA as a Biomarker in Pancreatic Cancer Patients Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT04616131
- Acronym / sponsor ID
- NU 20I05 WR
- Conditions
- Pancreas Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For patients who have been diagnosed with pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes. The purpose of this research study is to understand if we are able to detect pancreatic cancer DNA in the blood stream before, during, and after treatment.
Detailed description
Cancer DNA in the blood stream is called circulating tumor DNA or ctDNA. The presence or absence of pancreatic cancer ctDNA in the blood stream may help clinicians to better understand pancreatic cancer behavior in response to specific treatments, like chemotherapy and surgery. Understanding how treatment alters the ctDNA can help future patients diagnosed with pancreatic cancer. The presence or absence of ctDNA or the clearance of ctDNA after treatment may help to guide further treatment decisions for cancer patients after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female individuals age 18 and over planning to receive chemotherapy for pancreatic cancer that has not spread outside of the pancreas and nearby lymph nodes.
Key inclusion criteria (4 listed)
- Biopsy or cytology proven adenocarcinoma of the pancreas
- No clinical evidence of metastatic disease on imaging
- Age 18 or older
- Receiving chemotherapy for non-metastatic pancreatic cancer
Key exclusion criteria (1 listed)
- Biopsy proven metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected.
Time frame: 3 months
Utilizing Tempus, a commercial laboratory ctDNA genetic profile panel investigators will analyze the number of patients who had detectable ctDNA in their blood prior to neoadjuvant chemotherapy who then had no detectable ctDNA after their chemotherapy treatment.
1 secondary outcome
Investigators will look for statistically significant correlations of ctDNA blood levels with clinical treatment responses of tumor grades, CA 19-9 units/milliliter blood level, and radiologic response by RECIST categories of complete response.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akhil Chawla, MD principal investigator
Northwestern Medicine Warrenville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer, run by Northwestern University at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 18 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 3 sites 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?
Contact Study Coordinator (3126951301, cancertrials@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with circulating tumor DNA (ctDNA) levels as not detectable in their blood compared to number of patients with ctDNA detected. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.