Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02414100
• Other study ID #: 13C.628
• Secondary ID: 2013-077
• Status: Withdrawn
• Phase: N/A
• First received: March 19, 2015
• Last updated: September 5, 2017
• Start date: December 12, 2013
• Est. completion date: December 15, 2016

Study information

• Verified date: September 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot research trial studies patient derived cancer cell lines in identifying molecular changes in patients with previously untreated pancreatic cancer and are receiving gemcitabine hydrochloride-based chemotherapy. Cell lines refer to samples taken from the patient's tumor to grow for many months or years in a laboratory, and can therefore be studied scientifically. Studying cell lines in the laboratory may help doctors understand the genetic changes that occur to the tumor during chemotherapy that allows the tumor to resist or grow despite treatment.

Description:

PRIMARY OBJECTIVES:

I. Compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment.

SECONDARY OBJECTIVES:

I. Additional molecular patterns, beyond genetics, will be analyzed, including ribonucleic acid (RNA) and protein expression.

OUTLINE:

Tissue and blood samples are collected for genetic analysis via sequencing from patients receiving gemcitabine hydrochloride intravenously or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation. Chemotherapy is not part of the protocol. Per standard of care, patients receive gemcitabine hydrochloride (IV) the first 3 of 4 weeks (qw 3/4 wk) or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation IV qw 3/4 wk in the absence of disease progression or recurrence.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Suspected or confirmed pancreatic adenocarcinoma, any stage

2. >18 years of age

3. No prior systemic chemotherapy for pancreatic cancer, or currently undergoing first-line treatment for pancreatic cancer, or completed only first-line treatment for pancreatic cancer

4. A plan to undergo gemcitabine-based chemotherapy at Thomas Jefferson or a collaborating institution

5. Abdominal/pelvic CT scan or MRI within 4 months of the study

6. Signed study-specific informed consent

Exclusion Criteria:

1. Pregnancy

2. Prior systemic chemotherapy for pancreatic cancer

3. Gender/Minority/Pediatric Inclusion for Research

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Stage IA Pancreatic Cancer
• Stage IB Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer
• Stage III Pancreatic Cancer
• Stage IV Pancreatic Cancer

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Cytology Specimen Collection Procedure
Correlative studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls	This method includes a preprocessing step to filter out unreliable reads, a statistical classification step to identify point mutations that differ from both the reference genome hg19 and the control sample at controlled false-positive rate, and a post-processing step to eliminate platform-specific artifacts inherent in next generation sequencing. ANNOVAR software will then be used to analyze candidate point mutations for their predicted impact on protein function, which will be used to select and prioritize specific mutations for validation and/or further study.	Up to 5 years
Primary	Identification of germline mutations in known cancer genes from whole blood genomic deoxyribonucleic acid, and somatic mutations in conditionally reprogrammed cells derived from pre-treatment and post-treatment (e.g., resistant) tumors	The study will be considered a positive study if in any of the patients' samples, unique mutations are identified in the post-treatment derived cell lines that are not present in the pre-treatment derived cell lines from the same patient.	Up to 5 years

External Links

•   Jefferson University Hospitals
•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center