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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
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Adenocarcinoma Diagnostic Test: CTC isolocation and analysis

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced pancreatic adenocarcinoma.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Stage IV Pancreatic Cancer
FOLFIRINOX
gem/nab-P chemotherapy
17-042
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases