To assess in a cohort of patients with established FAP:1 The efficacy of MPA in terms of reduction of number of colonic polyps, by means of Endoscopic Appearance of Polyposis (EAP) index.2 The effect on histological parameters and biological…
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in adenoma number or density.
Secondary outcome
Changes in biological and histological parameters.
Background summary
The use of progestins in combination with estrogen is associated with a reduced
incidence of colorectal carcinoma (CRC). Also, incidental literature has
reported a coincidence of the start of oral contraceptive agents with reduction
in polyp number in a girl with Familial Adenomatous Polyposis (FAP)3. In this
study we test the hypothesis that progestins may reduce reduction polyp burden
in patients with Familial Adenomatous Polyposis (FAP), a familial polyposis
syndrome.
Study objective
To assess in a cohort of patients with established FAP:
1 The efficacy of MPA in terms of reduction of number of colonic polyps, by
means of Endoscopic Appearance of Polyposis (EAP) index.
2 The effect on histological parameters and biological response of MPA
medication.
Study design
This is an open label, proof-of-principle study in which 10 female patients
will receive MPA (Provera, Pfizer BV) 10 mg/day orally for 4 months. At
baseline and four months patients will undergo colonoscopy, with video
recording and taking of biopsies. Videos will be assessed for Endoscopic
Appearance of Polyposis (EAP) index by an expert panel of gastroenterologists.
Biopsies will be assessed for cell proliferation, apoptosis and targets of
progesterone signaling.
Intervention
All patients receive MPA (Provera, Pfizer BV) in a daily dosage of 10 mg for
four months.
Study burden and risks
Two colonoscopies will be performed. This is usually regarded as having a low
burden. With a colonoscopy there is a small risk for complications (0.1%).
These are generally treated by admitting and observing the patient for a short
time. Treatment with MPA carries smalli risks as discribed in the medication
folder.
albinusdreef 2
2333 ZA Leiden
Nederland
albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
• Females > 14 years of age
• Established FAP, confirmed by prior colonoscopy
• Patients must be able to adhere to the study visits and protocol requirements
• Patients must be able to give written informed consent. In case of a minor, parents/legal representative must be able to give a written consent. The consent must be obtained prior to any screening procedures
Exclusion criteria
• Prior progestin use in the past year
• Change in the use of NSAIDs at least 3 month prior to the study
• Allergic reaction on MPA during previous use
• Female patients who are pregnant or breast-feeding.
• Prior thromboflebitis or thromboembolism.
• Previous or current serious cardiac or cerebrovascular condition. Like thromboflebitis or thromboembolism, severe hypertension, severe liverfunction disorders. A history of jaundice, herpes gestationis non-explained vaginal bleeding or deterioration of otosclerosis during pregnancy or use of female hormones.
• Male and female patients with fertility wish for the study period
• Not available for follow-up assessment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-007477-23-NL |
| CCMO | NL21328.058.08 |