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

NCT02414100 | Withdrawn DMC

• 3 other identifiers: 13C.6282013-077JT 5543
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Patient derived cancer cell lines

Patients receive gemcitabine hydrochloride IV 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 per standard of care. Tissue and blood samples are collected for genetic analysis via sequencing.

Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Patient derived cancer cell lines

Cytology Specimen Collection Procedure OTHER

Correlative studies

Also known as: Cytologic Sampling

Patient derived cancer cell lines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with treatment naive pancreatic ductal adenocarcinoma (PDA) treated at Thomas Jefferson University or Georgetown University

You may qualify if:

• Suspected or confirmed pancreatic adenocarcinoma, any stage
• \>18 years of age
• 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
• A plan to undergo gemcitabine-based chemotherapy at Thomas Jefferson or a collaborating institution
• Abdominal/pelvic CT scan or MRI within 4 months of the study
• Signed study-specific informed consent

You may not qualify if:

• Pregnancy
• Prior systemic chemotherapy for pancreatic cancer

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Celgene: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jordan Winter, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: April 10, 2015
• Study Start: December 12, 2013
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)