Predicting Effective Therapy in Pancreatic Cancer
Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
1 other identifier
observational
74
1 country
4
Brief Summary
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2017
CompletedFirst Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2027
April 27, 2026
April 1, 2026
10 years
January 25, 2017
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
36 months
Study Arms (1)
Participants with Stage IV Pancreatic Cancer
Interventions
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
Eligibility Criteria
Patients with advanced pancreatic adenocarcinoma.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Publications (1)
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.
PMID: 35647938DERIVED
Related Links
Biospecimen
Sodium heparin tube collections will be performed at baseline, at each restaging CT scan and at time of first disease progression. K3-EDTA tubes will be collected at baseline and at disease progression. In patients who are planning an EGD for the purpose of obtaining a tumor biopsy, portal vein sampling will be offered. Under EUS guidance, a 19-gauge EUS fine needle will be advanced transhepatically into the portal vein and as many as four 7.5 mL K3-EDTA samples of blood will be aspirated, as previously described. Research biopsy will be performed at baseline and, if feasible, at disease progression.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 27, 2017
Study Start
January 24, 2017
Primary Completion (Estimated)
January 24, 2027
Study Completion (Estimated)
January 24, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04