Familial Adenomatous PolyposisNCT02656134
Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)
An observational study of Familial Adenomatous Polyposis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- Duodenoscopy and enteroscopy and Molecular analysis.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.
Who may be able to join
- Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.
Who cannot join
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo Medical School
São Paulo
Adriana Vaz Safatle-Ribeiro, MD, PhD
adrisafatleribeiro@terra.com.br
About this study
Official title: Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis
Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- Duodenoscopy and enteroscopy, Molecular analysis.
- Keywords
- Familial Adenomatous Polyposis
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenoscopy and enteroscopyProcedure or surgery
All patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy.
Molecular analysis.Genetic
Also called Immunohistochemistry
DNA analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic profile in FAP patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianny Sulbaran, University of Sao Paulo
- Investigators
- Marianny Sulbaran, MD, Principal investigator, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656134
- Sponsor's protocol ID
- Small bowel profile in FAP
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA. Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950.
PubMed 26265988Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ. Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10. doi: 10.1136/jcp.47.8.709.
PubMed 7962621Groves CJ, Saunders BP, Spigelman AD, Phillips RK. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41. doi: 10.1136/gut.50.5.636.
PubMed 11950808Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N. Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.
PubMed 21416262
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis: A Prospective Clinical, Immunopathologic and Molecular Analysis
- ClinicalTrials.gov ID
- NCT02656134
- Acronym / sponsor ID
- Small bowel profile in FAP
- Conditions
- Familial Adenomatous Polyposis
- Keywords
- Familial Adenomatous Polyposis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.
Key inclusion criteria (1 listed)
- Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.
Key exclusion criteria (1 listed)
- Pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duodenoscopy and enteroscopyAll patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy. | Procedure or surgery | – |
| Molecular analysis.Also: ImmunohistochemistryDNA analysis | Genetic | – |
Primary outcome
Genetic profile in FAP patients
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Background: PubMed 26265988Campos FG, Sulbaran M, Safatle-Ribeiro AV, Martinez CA. Duodenal adenoma surveillance in patients with familial adenomatous polyposis. World J Gastrointest Endosc. 2015 Aug 10;7(10):950-9. doi: 10.4253/wjge.v7.i10.950.
- Background: PubMed 7962621Spigelman AD, Talbot IC, Penna C, Nugent KP, Phillips RK, Costello C, DeCosse JJ. Evidence for adenoma-carcinoma sequence in the duodenum of patients with familial adenomatous polyposis. The Leeds Castle Polyposis Group (Upper Gastrointestinal Committee). J Clin Pathol. 1994 Aug;47(8):709-10. doi: 10.1136/jcp.47.8.709.
- Background: PubMed 11950808Groves CJ, Saunders BP, Spigelman AD, Phillips RK. Duodenal cancer in patients with familial adenomatous polyposis (FAP): results of a 10 year prospective study. Gut. 2002 May;50(5):636-41. doi: 10.1136/gut.50.5.636.
- Background: PubMed 21416262Mathus-Vliegen EM, Boparai KS, Dekker E, van Geloven N. Progression of duodenal adenomatosis in familial adenomatous polyposis: due to ageing of subjects and advances in technology. Fam Cancer. 2011 Sep;10(3):491-9. doi: 10.1007/s10689-011-9433-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianny Sulbaran, MD principal investigator
PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Adenomatous Polyposis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianny Sulbaran, MD (5511 948526841, mariannysulbaran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic profile in FAP patients (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02656134, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.