Pancreatic Ductal AdenocarcinomaNCT02414100
Patient Derived Cancer Cell Lines in Identifying Molecular Changes in Patients With Previously Untreated Pancreatic Cancer Receiving Gemcitabine Hydrochloride-Based Chemotherapy
An observational study of Pancreatic Ductal Adenocarcinoma and Stage IA Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer
- What is being tested?
- Laboratory Biomarker Analysis and Cytology Specimen Collection Procedure
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2013to 15 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with treatment naive pancreatic ductal adenocarcinoma (PDA) treated at Thomas Jefferson University or Georgetown University
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Prior systemic chemotherapy for pancreatic cancer
- Gender/Minority/Pediatric Inclusion for Research
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer
- Being tested
- Laboratory Biomarker Analysis, Cytology Specimen Collection Procedure
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Laboratory Biomarker Analysis; Other: Cytology Specimen Collection Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study start12 Dec 2013
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Why it stopped: No subjects were enrolled. Study team was not able to grow cell lines for the tumors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Jordan Winter, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414100
- Sponsor's protocol ID
- 13C.628
- Other IDs
- 2013-077, JT 5543
- Status last verified
- May 2025
- First submitted
- 19 Mar 2015
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Patient Derived Pancreatic Cancer Cell Lines to Determine Mechanisms of Chemoresistance
- ClinicalTrials.gov ID
- NCT02414100
- Acronym / sponsor ID
- 13C.628
- Conditions
- Pancreatic Ductal Adenocarcinoma, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled. Study team was not able to grow cell lines for the tumors.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- Compare the genetic profile of the tumor after progression has occurred, to the tumor prior to treatment.
SECONDARY OBJECTIVES:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient derived cancer cell lines | – | Other: Laboratory Biomarker Analysis, Other: Cytology Specimen Collection ProcedurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treatment naive pancreatic ductal adenocarcinoma (PDA) treated at Thomas Jefferson University or Georgetown University
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Prior systemic chemotherapy for pancreatic cancer
- Gender/Minority/Pediatric Inclusion for Research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Patient derived cancer cell lines |
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingCorrelative studies | Other | Patient derived cancer cell lines |
Primary outcome
Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls
Time frame: Up to 5 years
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.
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
Time frame: Up to 5 years
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Jefferson University HospitalsLink provided by the sponsor.
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RecruitingPhase 1
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Winter, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma and Stage IA Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic profiles of post-treatment samples with acquired resistance against pre-treatment and germline controls (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.