UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018736 |
|---|---|
| Receipt number | R000021673 |
| Scientific Title | Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine |
| Date of disclosure of the study information | 2015/08/21 |
| Last modified on | 2021/10/29 15:52:24 |
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Basic information
Public title
Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine
Acronym
Japan FAP prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine (J-FAPP Study 4)
Scientific Title
Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine
Scientific Title:Acronym
Japan FAP prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine (J-FAPP Study 4)
Region
| Japan |
Condition
Condition
familial adenomatous polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the colorectal tumor preventive effect of aspirin enteric coated tablet (100 mg/day) and/or mesalazine (2 g/day) in patients with familial adenomatous polyposis in a double-blind, 2 by 2 factorial design, randomized study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The primary endpoint is set as the incidence of recurrence / development of colorectal polyps that more than 5.0 mm in diameter after 8 months oral administration of low-dose aspirin and/or mesalazine.
Key secondary outcomes
Maximum diameter and histology of the colorectal polyps more than 5.0 mm in size after 8 months oral administration of low-dose aspirin and/or mesalazine.
The change of all the number of the colorectal polyps smaller than 5.0 mm in diameter are compared between pre and post administration of low-dose aspirin and/or mesalazine. (The changes of polyp number are assessed by at least three medical specialists for colon endoscopy in a blinded manner with several endoscopic photographs in the cecum, the splenic flexure and the lower part of the rectum.)
The change of number of the upper gastrointestinal tumor, such as gastric adenoma and duodenal adenoma, are compared between pre and post administration of low-dose aspirin and/or mesalazine.
The occurrence of adverse events.
The incidence of recurrence /development of colorectal polyps more than 5.0 mm in diameter at 8-12 months after cessation of administration of low-dose aspirin and/or mesalazine.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
aspirin (100 mg/day) + mesalazine (2 g/day), for eight months
Interventions/Control_2
aspirin (100 mg/day) + placebo, for eight months
Interventions/Control_3
placebo + mesalazine (2 g/day), for eight months
Interventions/Control_4
placebo + placebo, for eight months
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Candidate patients have to meet all the following inclusion criteria to participate in
the study.
# Patients with familial adenomatous polyposis (Participants in the J-FAPP Study III or the J-FAPP Study III-2).
# Familial adenomatous polyposis is defined as the presence of more than 100 adenomas in the colorectum including the past.
# The patients had been excised their all colorectal polyps more than 5.0 mm in diameter by endoscopy before the trial starts.
# The patients who could receive the last endoscopy examination performed 8 months after administration of low-dose aspirin and/or mesalazine.
Key exclusion criteria
# Patients currently taking antithrombotics such as Bayaspirin, Panaldine, Warfarin and Persantin etc.
# Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study).
# Patients with a history of stroke including transient ischemic attack.
# Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study)
# Patients with inflammatory bowel disease (ulcerative colitis, Crohn syndrome), bleeding diverticulosis, bleeding gastritis.
# Patients with bleeding tendency, a platelet count of < 100,000 /mm3, or with abnormal prothrombin time, or white blood cell count of 3,000 /mm3.
# Patients with any existing cancer at the time of participation in the trial, excluding radical cure of cancer, thyroid cancer and prostate cancer.
# Patients currently taking anticancer drugs.
# Patients with known allergy to aspirin or mesalazine.
# Women who are or may be pregnant during the study period.
# Patients currently taking NSAIDs at least 3 times weekly, for example, as an analgesic.
# Patients who took NSAIDs, such as sulindac, for the purpose of cancer chemoprevention but not pass 6 months at the time of the trial start. (Patients taking a lactic acid products such as BIOLACTIS POWDER; are allowed to participate in the trial.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
cancer@gol.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular-Targeting Cancer Prevention
Zip code
541-0042
Address
3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan
TEL
06-6202-5444
Homepage URL
cancer@gol.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
602-8566 Kyoto-shi, Kamigyo-ku Kajii-cho
Tel
075-251-5337
rinri@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
がん研有明病院（東京)
国立がん研究センター東病院（千葉県）
石川消化器内科（大阪府）
埼玉医科大学総合医療センター（埼玉県）
兵庫医科大学病院（兵庫県）
近畿大学医学部附属病院（大阪府）
群馬中央総合病院（群馬県）
栃木県立がんセンター（栃木県）
東邦大学医療センター大橋病院（東京都）
札幌医科大学附属病院（北海道）
佐野病院（兵庫県）
徳島大学病院（徳島県）
大阪府立成人病センター（大阪府）
愛知県がんセンター中央病院（愛知県）
東芝病院（東京都）
広島大学病院（広島県）
岩国医療センター（山口県）
石川県立中央病院（石川県）
国立がん研究センター中央病院（東京都）
産業医科大学（福岡県）
四国がんセンター（愛媛県）
京都大学医学部附属病院（京都府）
医療法人彩樹守口敬任会病院（大阪府）
宝塚市立病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Not posted
Publication of results
Published
Result
URL related to results and publications
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00018-2/fullte
Number of participants that the trial has enrolled
102
Results
The crude odds ratio (95% confidence interval) was 0.43 (0.19-0.97) with aspirin administration. On the other hand, the crude odds ratio (95% confidence interval) of the mesalazine-administered group was 0.87 (0.39-1.96).In a low-dose aspirin administration clinical trial targeting unoperated FAP, it was clarified that the frequency of colorectal polyp growth, which is the main endpoint, can be safely suppressed.
Results date posted
| 2021 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Under sub analysis
Date of the first journal publication of results
Baseline Characteristics
Currently, the only established treatment for preventing colorectal cancer in patients with familial adenomatous polyposis (FAP) is colectomy, which greatly reduces patient quality of life. Thus, an alternative method is warranted. This trial aimed to clarify the effects of low-dose aspirin and mesalazine on the recurrence of colorectal polyps in Japanese FAP patients without a history of colectomy.
Participant flow
Here we conducted a randomized, double-blind, placebo-controlled multi-center trial with a 2 x 2 factorial design to determine the individual and joint effects of low-dose aspirin and mesalazine on the recurrence of colorectal polyps in Japanese FAP patients without a history of colectomy. Patients were eligible if they were aged 16-70 years. Diagnostic criteria used for FAP is patients who had a history of more than 100adenomatous polyps in the large intestine or detection of APC mutation. For randomization, a minimization method with a random component was used to balance the groups with respect to the following adjustment factors: sex, age (Less than 30 years vs. more than 30 years), and smoking status at the time of entry as stratification factors. The primary endpoint was the incidence of colorectal polyps 5.0 mm or more at 8 months. Safety was assessed in all patients. The primary endpoint was analyzed based on intention-to-treat. In addition, we performed a separate analysis including only patients who took at least 70% of the allocated study drug (the per-protocol analysis). This trial is registered with umin.ac.jp, number: UMIN000018736.
Adverse events
No serious adverse events were observed.
Outcome measures
The main endpoint was the presence or absence of colorectal polyps of 5.0 mm or larger at 8 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021673
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/07/08 | J-FAPP.xlsx |
