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, 2020
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer Pancreatic Adenocarcinoma||Diagnostic Test: CTC isolocation and analysis|
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|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, 2022|
|Estimated Study Completion Date :||January 24, 2022|
|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.
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|