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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

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 27, 2017
Last Update Posted Date August 31, 2022
Actual Study Start Date January 24, 2017
Estimated Primary Completion Date January 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 22, 2017)		 Progression Free Survival [ Time Frame: 36 months ]
in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis
Original Primary Outcome Measures
 (submitted: January 25, 2017)		 Progression Free Survival [ Time Frame: 36 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Effective Therapy in Pancreatic Cancer
Official Title Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response
Brief Summary The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.
Sampling Method Probability Sample
Study Population Patients with advanced pancreatic adenocarcinoma.
Condition
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
Intervention Diagnostic Test: CTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
Study Groups/Cohorts Participants with Stage IV Pancreatic Cancer
Intervention: Diagnostic Test: CTC isolocation and analysis
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 27, 2020)		 74
Original Estimated Enrollment
 (submitted: January 25, 2017)		 80
Estimated Study Completion Date January 24, 2024
Estimated Primary Completion Date January 24, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03033927
Other Study ID Numbers 17-042
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor Memorial Sloan Kettering Cancer Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2022