Clinical trialObsWithdrawn
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
- Outcome
- Stopped earlyNo subjects were enrolled. Study team was not able to grow cell lines for the tumors. (Enrollment)
- Phase
- Obs
- Status
- Withdrawn
- Study type
- Observational
- Start
- 12 December 2013
- Expected end
- 15 December 2016
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls; 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
- Sponsor
- Other
- Results posted
- No
- Last update
- 2 May 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.