Clinical trial · Observational
Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy
Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No subjects were enrolled. Study team was not able to grow cell lines for the tumors.
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient derived cancer cell lines
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Cytology Specimen Collection Procedure
Primary outcomes (2)
- measure
- Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls
- timeFrame
- Up to 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available