Pancreas CystNCT03855800
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
A study testing Blood, stool, pancreatic juice and cyst fluid collection, Pancreatic Surgery and Endoscopy Exam in people with Pancreas Cyst, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreas Cyst
- What is being tested?
- Blood, stool, pancreatic juice and cyst fluid collection, Pancreatic Surgery and Endoscopy Exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2018to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
- Patients with suspected cystic neoplasm of the pancreas
- Able to provide written informed consent
Who cannot join
- Pregnant and/or nursing
- Incarceration
- Imaging showing possible pancreatic cancer
- Prior history of pancreatic cancer or pancreatic surgery
- History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
- Previous therapy for a pancreatic cystic lesion
- History of pancreatic necrosis
- Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
IN-CYST Team, 833-250-5364 ext. 2, rstincyststudy@mayo.edu
Shounak Majumder, MD
About this study
Official title: Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.
Read the detailed description
Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.
- Conditions
- Pancreas Cyst
- Being tested
- Blood, stool, pancreatic juice and cyst fluid collection, Pancreatic Surgery, Endoscopy Exam
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, stool, pancreatic juice and cyst fluid collectionDiagnostic test
Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.
Pancreatic SurgeryProcedure or surgery
Surgical resection of pancreatic cyst
Endoscopy ExamProcedure or surgery
Clinically indicated endoscopic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Clinical Follow-up | Experimental | Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted Receives: Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Endoscopy Exam |
| Surgical | Other | Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known. Receives: Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection; Procedure: Pancreatic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen Acquisition
Number of biospecimens collected
Measured: 5 years
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection
Measured: 5 years
Secondary outcomes (1)
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group
To evaluate the performance of cyst fluid MDM assays for predicting development of HGD or cancer during 3-year follow-up in study patients who are initially managed non-operatively
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start11 May 2018
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
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 Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shounak Majumder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855800
- Sponsor's protocol ID
- 17-008436
- Other IDs
- 2U01CA210138
- Status last verified
- May 2026
- First submitted
- 31 Jan 2019
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
- ClinicalTrials.gov ID
- NCT03855800
- Acronym / sponsor ID
- 17-008436
- Conditions
- Pancreas Cyst
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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.
Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.
Detailed description
Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Follow-up | Experimental | Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection, Procedure: Endoscopy ExamParticipants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted |
| Surgical | Other | Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection, Procedure: Pancreatic SurgeryParticipants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
- Patients with suspected cystic neoplasm of the pancreas
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- Pregnant and/or nursing
- Incarceration
- Imaging showing possible pancreatic cancer
- Prior history of pancreatic cancer or pancreatic surgery
- History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
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 |
|---|---|---|
| Blood, stool, pancreatic juice and cyst fluid collectionBlood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam. | Diagnostic test | Clinical Follow-up, Surgical |
| Pancreatic SurgerySurgical resection of pancreatic cyst | Procedure or surgery | Surgical |
| Endoscopy ExamClinically indicated endoscopic ultrasound | Procedure or surgery | Clinical Follow-up |
Primary outcome
Biospecimen Acquisition
Time frame: 5 years
Number of biospecimens collected
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
Time frame: 5 years
To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection
1 secondary outcome
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shounak Majumder, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, stool, pancreatic juice and cyst fluid collection, Pancreatic Surgery and Endoscopy Exam in people with Pancreas Cyst, run by Mayo Clinic 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IN-CYST Team (1-833-250-5364 ext. 2, rstincyststudy@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen Acquisition (time frame: 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 Jun 2026.