Status:
COMPLETED
The CHAMP-study: The CHemopreventive Effect of Lithium in Familial AdenoMatous Polyposis
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
18-35 years
Phase:
PHASE2
Brief Summary
Rationale: Familial adenomatous polyposis (FAP) syndrome is characterized by the development of numerous colorectal polyps. If left untreated, these patients have a chance of nearly 100% of developing...
Detailed Description
For this study, monitoring was requested from Clinical Monitoring Center (CMC). After approval by the METC, a monitoring intake visit will be scheduled to set up a monitoring plan. In this study, no ...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria for inclusion in the study:
- Age between 18 and 35 years;
- Confirmed APC germline mutation and one of the following:
- Minimum of 100 colorectal adenomas
- Minimum of 50 colorectal adenomas and a positive family history of a classical FAP phenotype (\>100 colorectal adenomas);
- Intact colon;
- Participant is willing and able to give informed consent for participation.
Exclusion
- Patients that meets any of the following criteria will be excluded from participation in this study:
- Participation in any other clinical intervention study; observational trials accepted;
- Lithium use prior to participation of the study;
- Pregnancy, breast-feeding or no use of anticonception;
- No normal intestinal mucosa left for normal tissue biopsy;
- Indication for colectomy within 2 years;
- Known renal impairment, defined as GFR \< 60 ml/min;
- Known severe cardiac disorder;
- Known severe brain injury;
- Hypothyroidism;
- Hyponatremia, defined as Na \< 130mmol/L;
- Positive family history of Brugada syndrome
- Co-medication known for interacting with lithium
- Regular NSAID use (defined as more than twice a week for 4 consecutive weeks) within 3 months prior to baseline;
- Use of immunosuppressive or anti-inflammatory drugs within 3 months prior to baseline;
- Use of any other FAP directed drug therapy within 3 months prior to baseline (use of any alternative supplements e.g. turmeric or fish-oil must be noted in questionnaire).
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05402891
Start Date
June 2 2022
End Date
September 30 2024
Last Update
October 4 2024
Active Locations (1)
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1
Academic Medical Centre
Amsterdam, North Holland, Netherlands, 1105AZ