Oral Contraceptive Induced Hepatic Adenomas: Building a Biorepository

Study on Liver Tumors in Birth Control Users

C
Craig Lammert, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
4 Locations

Brief description of study

The purpose of this study is to collect biosamples, in the form of whole blood, saliva, and tissue when available, to create a biorepository for people who have a hepatic adenoma or focal nodular hyperplasia (FNH) or both. Our goal is to find out why some women taking birth control pills develop rare liver tumors called hepatic adenomas.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Prospective participants will be clinic patients of the study investigators and will be recruited in-person at the time of their clinic appointment.  Subjects who have a hepatic adenoma or FNH will be invited to participate in the study. They will be identified by medical record review or at their doctor's visit.

Detailed description of study

The aim of this proposal is to collect biological samples and selected phenotype data from patients taking oral contraceptives who did or did not develop hepatic adenomas. At one study visit, subjects donate 50 mL of blood, about 2mL of saliva and answer an environmental questionnaire. A piece of tissue will be taken and stored if the adenoma or FNH are resected. For participants who participate remotely, the informed consent process will be conducted via telephone or televideo. The survey can be mailed or a link can be emailed or sent via text directly from RedCap to complete the survey. For this group, a saliva kit with instructions and return postage will be mailed for sample capture and whole blood will not be collected.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatic adenoma, Focal nodular hyperplasia, FNH
  • Age: 18 years or above
  • Gender: All

Inclusion criteria:
  • Men and women ≥ 18 years with hepatic adenoma or FNH evident on CT or MRI imaging radiologic criteria

This study investigates why some women who take birth control pills develop rare liver tumors called hepatic adenomas. Hepatic adenomas are non-cancerous liver tumors. The study will collect samples like blood, saliva, and tissue from people with hepatic adenomas or focal nodular hyperplasia (FNH), which is another type of liver growth.

Participants will visit once to donate blood, saliva, and answer a questionnaire about their environment. Tissue samples will be taken if the adenoma or FNH is surgically removed. For those participating remotely, saliva samples will be collected using a mailed kit, and questionnaires will be completed online or by mail.

  • Who can participate: Men and women aged 18 years or older with hepatic adenoma or FNH, identified through CT or MRI scans, can participate.
  • Study details: Participants will provide blood and saliva samples and answer a questionnaire. Remote participants will send saliva samples by mail and complete surveys online or by mail.
  • Study visits: The study requires 1 visit.
Updated on 16 Dec 2025. Study ID: GI-IIR-LAMMERT-ADENOMA, 1302010753
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only