Aurora, CONCT04181138Now EnrollingIRB Ready

Primary Sclerosing Cholangitis Clinical Trial in Aurora, CO

Access cutting-edge primary sclerosing cholangitis treatment through this clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by Arbor Research Collaborative for Health

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Expert Care in Aurora

Access primary sclerosing cholangitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related primary sclerosing cholangitis treatment provided free

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Check if you qualify for this primary sclerosing cholangitis clinical trial in Aurora, CO

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Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This Primary Sclerosing Cholangitis Study in Aurora

Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver. The purposes of this study are to: * Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly. * Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning * Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.

Sponsor: Arbor Research Collaborative for Health

Who Can Participate

Inclusion Criteria

Patients with the clinical diagnosis of large or small duct PSC made at any time prior to enrollment are screened for eligibility to participate in this prospective cohort study. The site PI will determine eligibility following review of MRCP or ERCP images with the site radiologist to confirm presence of an abnormal cholangiogram at the time of diagnosis of large duct PSC. Liver histopathology obtained at the time of diagnosis of small duct PSC will be reviewed with the site pathologist prior to enrollment. Individuals must meet all of the Inclusion criteria in order to be eligible to participate in the study:
Aged 2 through 25 years at time of screening.
Diagnosis of large duct PSC based on review of cholangiogram by MRC, ERC, or intraoperative cholangiogram (IOC) by the site radiologist and interpreted to be consistent with PSC, based on one or more of the following:
Focal structuring of the bile duct(s)
Dominant stricture of the common bile duct
Saccular dilatation of bile duct(s)
Beaded appearance of bile duct(s)
Pruning appearance of the distal bile duct branches AND/OR
Diagnosis of small duct PSC based on review of liver histopathology by the site pathologist and interpreted to be compatible with PSC:
Probable small duct PSC: biopsy with ≥3 of 5 criteria: periductal edema, concentric inflammation, bile duct injury, ductular reaction, and neutrophils in bile ducts (cholangitis) OR...
Definitive small duct PSC: Periductal fibrosis/ "onion skinning" around interlobular bile ducts or smaller profiles
Stated willingness to comply with all study procedures and availability for the duration of the study.
Able to provide informed consent/assent Participants for the imaging study are eligible if they are:
Aged 8 through 25 years at the time of screening
No absolute contraindication to MRI
No skin condition that could be aggravated by MREL
Meet all other eligibility criteria of the PSC Observational Study
For whom none of the

Exclusion Criteria

apply Exclusion Criteria: An individual who meets any of the following criteria at baseline will be excluded from participation in this study.
History of liver transplantation
History bone marrow transplantation
History of primary or acquired immunodeficiency predisposing to secondary sclerosing cholangitis, for instance: hyper-IgM syndrome, severe combined immunodeficiency (SCID) syndrome, common variable immunodeficiency (CVID) syndrome, cartilage hair hypoplasia syndrome, or HIV/AIDS
History of histiocytosis, including Langerhans cell histiocytosis (LCH), or hemophagocytic lymphohistiocytosis (HLH)
History of ischemic cholangitis
History of portal vein thrombosis with biliopathy, veno-occlusive disease, or abdominal radiation vasculopathy
History of recurrent pyogenic cholangitis
History of biliary tract surgery for cholecystolithiasis prior to cholangiogram/liver biopsy evaluated to determine enrollment
History of biliary tract surgery for choledochal cyst
History of hepatocellular carcinoma, or hepatoblastoma
History of surgical biliary trauma
History of congenital cytomegalovirus (CMV) hepatitis
History of Sickle Cell Disease
History of cystic fibrosis, biliary atresia, Caroli disease/congenital hepatic fibrosis, or progressive familial intrahepatic cholestasis type 3/MDR3 disease
History of cardiac hepatopathy.
History of metabolic disorders, including Wilson's disease, glycogen storage disorder, Alpha-1 Antitrypsin deficiency
Diagnosis of systemic lupus erythematosus (SLE)
Concurrent pregnancy at the time of enrollment -

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT04181138) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Primary Sclerosing Cholangitis Treatment Options in Aurora, CO

If you're searching for primary sclerosing cholangitis treatment options in Aurora, CO, this clinical trial (NCT04181138) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced primary sclerosing cholangitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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