The chemopreventive effect of Lithium on adenoma development in patients with familial adenomatous polyposis (FAP); a pilot study - Lithium in FAP

Center for Experimental and Molecular Medicine, G2 (AMC)0 个研究点目标入组 12 人开始时间: 2022年4月8日最近更新: 2022年4月25日

适应症

试验速览

暂无简介。

•- Male or female between the age of 18 and 35 years;
•- Confirmed APC germline mutation;
•- Positive family history of a classical FAP phenotype (>100 colorectal adenomas);
•- Intact colon, with a minimum of 50 polyps;
•- Participant is willing and able to give informed consent for participation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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 (as defined in the protocol).
•- 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).

发起方

Center for Experimental and Molecular Medicine, G2 (AMC)