Aberrant Crypt FociNCT00176618
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
A study testing sulindac and curcumin in people with Aberrant Crypt Foci, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aberrant Crypt Foci
- What is being tested?
- sulindac and curcumin
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jun 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
- Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
Who cannot join
- Subjects must not have:
- Alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use
- Platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin.
- High risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis).
- Uncontrolled hypertension, diabetes, or chronic congestive heart failure.
- Renal insufficiency defined as a serum creatinine > 2.5 mg/dl
- History of colorectal surgery with removal of the distal 60 cm of colon or rectum.
- History of other gastrointestinal mucosal epithelial diseases (such as Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue or other disorders of nutrient absorption).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.
Read the detailed description
Laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. ACFs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.
- Conditions
- Aberrant Crypt Foci
- Being tested
- sulindac, curcumin
- Keywords
- Aberrant Crypt Foci
- Medical subject headings
- Aberrant Crypt Foci
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulindacDrug
Sulindac 150 mg po BID
curcuminDrug
Curcumin 250 mg po BID
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam
Measured: 48 months
Secondary outcomes (1)
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: principal Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aberrant Crypt FociStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Investigators
- Yang CS, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176618
- Sponsor's protocol ID
- 4611
- Other IDs
- CINJ#120305
- Status last verified
- Dec 2009
- First submitted
- 13 Sep 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
- ClinicalTrials.gov ID
- NCT00176618
- Acronym / sponsor ID
- 4611
- Conditions
- Aberrant Crypt Foci
- Keywords
- Aberrant Crypt Foci
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: principal Investigator left institution
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.
Detailed description
Laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. ACFs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
- Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
Key exclusion criteria (8 listed)
- Alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use
- Platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin.
- High risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis).
- Uncontrolled hypertension, diabetes, or chronic congestive heart failure.
- Renal insufficiency defined as a serum creatinine > 2.5 mg/dl
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 |
|---|---|---|
| sulindacSulindac 150 mg po BID | Drug | – |
| curcuminCurcumin 250 mg po BID | Drug | – |
Primary outcome
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam
Time frame: 48 months
1 secondary outcome
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment
Time frame: 48 months
Results and safety
The study was stopped early (reason given: principal Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
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.
Yang CS, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sulindac and curcumin in people with Aberrant Crypt Foci, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Dec 2009. 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 United States. 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?
The study was stopped early (reason given: principal Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2009.