Predicting Effective Therapy in Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03033927 |
Recruitment Status :
Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : August 31, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Pancreatic Cancer Pancreatic Adenocarcinoma | Diagnostic Test: CTC isolocation and analysis |
Study Type : | Observational |
Actual Enrollment : | 74 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response |
Actual Study Start Date : | January 24, 2017 |
Estimated Primary Completion Date : | January 24, 2024 |
Estimated Study Completion Date : | January 24, 2024 |

Group/Cohort | Intervention/treatment |
---|---|
Participants with Stage IV Pancreatic Cancer |
Diagnostic Test: CTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay. |
- Progression Free Survival [ Time Frame: 36 months ]in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
Biospecimen Retention: Samples With DNA
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033927
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center Basking Ridge | |
Basking Ridge, New Jersey, United States, 07920 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center @ Suffolk | |
Commack, New York, United States, 11725 | |
Memoral Sloan Kettering Westchester | |
Harrison, New York, United States, 10604 | |
Memorial Sloan Kettering Nassau | |
Uniondale, New York, United States, 11553 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT03033927 |
Other Study ID Numbers: |
17-042 |
First Posted: | January 27, 2017 Key Record Dates |
Last Update Posted: | August 31, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stage IV Pancreatic Cancer FOLFIRINOX gem/nab-P chemotherapy 17-042 |
Pancreatic Neoplasms Neoplasms Digestive System Neoplasms Neoplasms by Site |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |