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NCT03033927 Clinical Trial

Predicting Effective Therapy in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Circulating Tumor Cell and Tumor Tissue Models for Predicting Effective Pancreatic Cancer Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03033927
Other study ID # 17-042
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 24, 2017
Est. completion date January 24, 2025

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 74
Est. completion date January 24, 2025
Est. primary completion date January 24, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CTC isolocation and analysis
Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Suffolk Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival in patients receiving frontline therapy predicted to be effective versus ineffective based on CTC PGx analysis 36 months
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