Pancreatic CancerNCT03033927
Predicting Effective Therapy in Pancreatic Cancer
An observational study of Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- What is being tested?
- CTC isolocation and analysis
- How many people
- 74 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Jan 2017to 24 Jan 2027
- 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: Patients with advanced pancreatic adenocarcinoma.
Who may be able to join
- Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
- Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
- Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
- ECOG performance status 0-2.
- A minimum age of 18 years old.
Who cannot join
- Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
- Known to be HIV positive on antiretroviral therapy
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Being tested
- CTC isolocation and analysis
- Keywords
- Stage IV Pancreatic Cancer, FOLFIRINOX, gem/nab-P chemotherapy, 17-042
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC isolocation and analysisDiagnostic test
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Stage IV Pancreatic Cancer | Not described Receives: Diagnostic Test: CTC isolocation and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start24 Jan 2017
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033927
- Sponsor's protocol ID
- 17-042
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2017
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1.
PubMed 35647938
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
- ClinicalTrials.gov ID
- NCT03033927
- Acronym / sponsor ID
- 17-042
- Conditions
- Pancreatic Cancer, Pancreatic Adenocarcinoma
- Keywords
- Stage IV Pancreatic Cancer, FOLFIRINOX, gem/nab-P chemotherapy, 17-042
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- 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.
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Stage IV Pancreatic Cancer | – | Diagnostic Test: CTC isolocation and analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced pancreatic adenocarcinoma.
Key inclusion criteria (5 listed)
- Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
- Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
- Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
- ECOG performance status 0-2.
- A minimum age of 18 years old.
Key exclusion criteria (4 listed)
- Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
- Known to be HIV positive on antiretroviral therapy
- Prior organ allograft
- Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC isolocation and analysisCirculating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay. | Diagnostic test | Participants with Stage IV Pancreatic Cancer |
Primary outcome
Progression Free Survival
Time frame: 36 months
in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
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 27 Apr 2026.
- Derived from this study: PubMed 35647938Yu KH, Park J, Mittal A, Abou-Alfa GK, El Dika I, Epstein AS, Ilson DH, Kelsen DP, Ku GY, Li J, Park W, Varghese AM, Chou JF, Capanu M, Cooper B, Bartlett A, McCarthy D, Sangar V, McCarthy B, O'Reilly EM. Circulating tumor and invasive cell expression profiling predicts effective therapy in pancreatic cancer. Cancer. 2022 Aug 1;128(15):2958-2966. doi: 10.1002/cncr.34269. Epub 2022 Jun 1.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Solid Tumors
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Memorial Sloan Kettering Cancer Center at 4 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 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Progression Free Survival (time frame: 36 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 NCT03033927, which also lists 1 linked publication.
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 27 Apr 2026.