Pancreas CystNCT01807325
RNA Sequencing of Solid and Cystic Lesions of the Pancreas
An observational study of Pancreas Cyst and Pancreas Mass, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cyst, Pancreas Mass
- What is being tested?
- pancreas biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Dec 2019
- 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: adult, nonpregnant patients referred for endoscopic ultrasound to evaluate solid or cystic lesion of the pancreas.
Who may be able to join
- greater than 18 years old,
- not pregnant,
- referred for endoscopic ultrasound,
- have a cyst or mass of the pancreas needing diagnosis.
Who cannot join
- pregnant,
- less than age 18,
- no mass or cyst found.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence St Vincent Hospital
Portland, Oregon, 97229
Oregon Health and Science University
Portland, Oregon, 97239
About this study
The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.
- Conditions
- Pancreas Cyst, Pancreas Mass
- Being tested
- pancreas biopsy
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreas biopsyProcedure or surgery
Also called RNA sequencing of pancreas tissue
patients who are already having a pancreas biopsy will be invited to enroll. After obtaining enough tissue for usual medical care, we will divert some tissue for the study.
| Study group | Role | What they receive |
|---|---|---|
| pancreas cysts and solid masses | patents referred for solid and cystic lesions of the pancreas who will have a biopsy for usual medical care. Receives: Procedure: pancreas biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene classifier that will classify lesions as benign or malignant with 95% certainty
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CystStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services
- Responsible party
- Sponsor
- Investigators
- Sarah Rodriguez, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807325
- Sponsor's protocol ID
- IRB8317
- Status last verified
- Jan 2020
- First submitted
- 6 Mar 2013
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNA Sequencing of Solid and Cystic Lesions of the Pancreas
- ClinicalTrials.gov ID
- NCT01807325
- Acronym / sponsor ID
- IRB8317
- Conditions
- Pancreas Cyst, Pancreas Mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Providence Health & Services
- Study start
- Dec 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Mar 2013 (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 nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreas cysts and solid masses | – | Procedure: pancreas biopsypatents referred for solid and cystic lesions of the pancreas who will have a biopsy for usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult, nonpregnant patients referred for endoscopic ultrasound to evaluate solid or cystic lesion of the pancreas.
Key inclusion criteria (4 listed)
- greater than 18 years old,
- not pregnant,
- referred for endoscopic ultrasound,
- have a cyst or mass of the pancreas needing diagnosis.
Key exclusion criteria (3 listed)
- pregnant,
- less than age 18,
- no mass or cyst found.
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 |
|---|---|---|
| pancreas biopsyAlso: RNA sequencing of pancreas tissuepatients who are already having a pancreas biopsy will be invited to enroll. After obtaining enough tissue for usual medical care, we will divert some tissue for the study. | Procedure or surgery | pancreas cysts and solid masses |
Primary outcome
Gene classifier that will classify lesions as benign or malignant with 95% certainty
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
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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.
Sarah Rodriguez, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cyst and Pancreas Mass, run by Oregon Health and Science University at 2 sites 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 4 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: finished, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gene classifier that will classify lesions as benign or malignant with 95% certainty (time frame: 2 years). 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 Jan 2020.