Metastatic Pancreatic CancerNCT02205788
Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas
An observational study of Metastatic Pancreatic Cancer, run by Patrick Joseph Loehrer Sr..
Trial summary
The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to 14 Sep 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: primary care clinic and Cancer Clinic patients
Who may be able to join
- Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
- ≥ 18 years old at time of consent
- Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
- Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
- Measurable disease by RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
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- Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
- Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the start of protocol treatment.
- Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
- Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) < 1.2, Partial thromboplastin time (PTT) in normal range, Cr < 2.0, Total bilirubin < 2 times upper limit normal (ULN), transaminases < 5 times ULN
Who cannot join
- History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
- Women who are pregnant or breastfeeding
About this study
Official title: Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas
The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.
Read the detailed description
To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
- Conditions
- Metastatic Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI as a chemosensitivity assay on fresh tumor samples
To examine the feasibility of using BDI as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
Measured: up to 336 days
Secondary outcomes (1)
BDI patterns and results with Response Evaluation Criteria
To compare BDI patterns consistent with chemotherapy response ex-vivo to response to chemotherapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Measured: up to 336 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion14 Sep 2016
- Study completion14 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Joseph Loehrer Sr.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Joseph Loehrer Sr., Indiana University
- Investigators
- Bert O'Neil, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205788
- Sponsor's protocol ID
- IUCRO-0479
- Other IDs
- 1405049285
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2014
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Biodynamic Imaging for Predicting Effect of Gemcitabine and Nab-paclitaxel on Metastatic Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT02205788
- Acronym / sponsor ID
- IUCRO-0479
- Conditions
- Metastatic Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Patrick Joseph Loehrer Sr.University, hospital or other
- Study start
- Jul 2014
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 31 Jul 2014 (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.
The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.
Detailed description
To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic and Cancer Clinic patients
Key inclusion criteria (10 listed)
- Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
- ≥ 18 years old at time of consent
- Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
- Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
- Measurable disease by RECIST v1.1 criteria
Key exclusion criteria (2 listed)
- History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
- Women who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BDI as a chemosensitivity assay on fresh tumor samples
Time frame: up to 336 days
To examine the feasibility of using BDI as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.
1 secondary outcome
BDI patterns and results with Response Evaluation Criteria
Time frame: up to 336 days
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 10 Jul 2019.
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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.
Bert O'Neil, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Pancreatic Cancer, run by Patrick Joseph Loehrer Sr..
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 10 inclusion and 2 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
BDI as a chemosensitivity assay on fresh tumor samples (time frame: up to 336 days). 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 10 Jul 2019.