Early Detection of Pancreatic Cystic Neoplasms
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2014 |
| End Date: | March 2019 |
| Contact: | Kathy Judge |
| Email: | Romanka@jhmi.edu |
| Phone: | 4105027460 |
This research is being done to learn more about pancreatic cysts. The tests that are
currently available are imperfect at determining exactly what type of pancreatic cyst a
person has, which cysts contain cancer, or what the risk is of developing cancer in the
future. The aim of this study is to use a combination of clinical, imaging, cyst fluid
analysis, and molecular markers to try to help develop better tools to answer these
questions.
currently available are imperfect at determining exactly what type of pancreatic cyst a
person has, which cysts contain cancer, or what the risk is of developing cancer in the
future. The aim of this study is to use a combination of clinical, imaging, cyst fluid
analysis, and molecular markers to try to help develop better tools to answer these
questions.
Incidental pancreatic cysts are increasingly recognized due to the widespread use of
cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas
can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs),
intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and
pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered
malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with
malignant potential, although the exact risk of malignant progression of these cysts is
unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have
features suspicious for malignancy.
However, current diagnostic tests cannot always reliably distinguish harmless from
potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each
cyst type has unique genetic features that could be used as diagnostic biomarkers. In this
study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts
will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a
fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after
standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular
marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be
collected after the cyst has been removed. In addition, a small amount of blood will be
collected at the time of the EUS or surgical procedure.
AIMS: The general aim is to propose and prospectively validate a diagnostic approach and
model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant,
pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.
cross-sectional imaging techniques such as CT and MRI. A number of lesions in the pancreas
can form cysts, including serous cystadenomas (SCA), mucinous cystic neoplasms (MCNs),
intraductal papillary mucinous neoplasms (IPMNs), solid-pseudopapillary neoplasms (SPNs), and
pseudocysts. SCAs and pseudocysts are considered benign; whereas SPNs are considered
malignant and require surgical resection. IPMNs and MCNs are considered neoplasms with
malignant potential, although the exact risk of malignant progression of these cysts is
unknown. Currently, MCN are all surgically resected, whereas IPMN are resected if they have
features suspicious for malignancy.
However, current diagnostic tests cannot always reliably distinguish harmless from
potentially harmful cysts. Recent studies conducted at Johns Hopkins have shown that each
cyst type has unique genetic features that could be used as diagnostic biomarkers. In this
study, clinical, imaging data and cyst fluid analysis of individuals with pancreatic cysts
will be collected. In patients who undergo an endoscopic ultrasound (EUS) procedure, if a
fine needle aspiration (EUS-FNA) is performed, and there is extra cyst fluid left after
standard clinical tests have been sent, the extra cyst fluid will be submitted for molecular
marker analysis. If an individual undergoes surgery to remove the cyst, cyst fluid will be
collected after the cyst has been removed. In addition, a small amount of blood will be
collected at the time of the EUS or surgical procedure.
AIMS: The general aim is to propose and prospectively validate a diagnostic approach and
model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant,
pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.
Inclusion Criteria:
- Adult patients age 18 years and older with pancreatic cyst.
Exclusion Criteria:
- Individuals with ASA class 4 or greater.
- Inability to provide informed consent.
- Pregnancy or lactation.
We found this trial at
1
site
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
