Gainesville, FLNCT05199259Now EnrollingIRB Ready

Liver Cirrhosis Clinical Trial in Gainesville, FL

Access cutting-edge liver cirrhosis treatment through this clinical trial at a research site in Gainesville. Study-provided care at no cost to qualified participants.

Sponsored by Helio Genomics

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Expert Care in Gainesville

Access liver cirrhosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related liver cirrhosis treatment provided free

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Check if you qualify for this liver cirrhosis clinical trial in Gainesville, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Gainesville

    Convenient for FL 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 Gainesville site if eligible
  4. 4Begin participation

About This Liver Cirrhosis Study in Gainesville

The objective of this study is the acquisition of whole blood samples and serum samples from participants with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing Hepatocellular Carcinoma (HCC) surveillance. These samples will be used for research purposes to develop and validate the Helio multi-analyte blood test.

Sponsor: Helio Genomics

Who Can Participate

Inclusion Criteria

Age 18 years or older.
Males and Females.
Having cirrhosis or meeting the AASLD guidelines for HCC
surveillance.
Clinically diagnosed with HCC or negative for HCC following disease
surveillance.
HCC positive Group: Subject has a recent (within 6 months of enrollment) clinically diagnosed, untreated hepatocellular carcinoma as defined by at least one ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.
HCC negative Group: Non-cancer, at-risk subjects with chronic liver disease undergoing routine imaging surveillance for HCC, where the definitive lack of HCC within 3 months prior to enrollment has been verified by negative imaging, for HCC. No more than 200 subjects without cirrhosis can be enrolled in this group.
Sub-Group 1 (approximately 450 subjects) - negative by CT or MRI (No lesion, LR-1 or LR-2)
Sub-Group 2 (approximately 450 subjects) - negative by ultrasound

Exclusion Criteria

Subjects that are unwilling or unable to sign the Informed Consent Form will be excluded.
Known cancer diagnosis of a cancer other than HCC within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
Prior treatment with a DNA methyltransferase inhibitor such as with Vidaza (azacitidine) or Dacogen (decitabine)
Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
IV contrast (e.g., CT and MRI) within 1 day \[or 24 hours\] of blood collection.
Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
For HCC negative subjects, patients with a prior diagnosis of HCC are also excluded.
Subjects that are pregnant will be exclude

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 Gainesville?

Yes, this clinical trial (NCT05199259) has an active research site in Gainesville, FL 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.

Liver Cirrhosis Treatment Options in Gainesville, FL

If you're searching for liver cirrhosis treatment options in Gainesville, FL, this clinical trial (NCT05199259) 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 Gainesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced liver cirrhosis 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.

Looking for more options? Browse all liver cirrhosis clinical trials near you to find additional studies recruiting in your area.

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