Colorectal Adenomatous PolypsPPS4BNCT00399607
Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention
An observational study of Colorectal Adenomatous Polyps, run by Emory University at 9 sites in United States.
Trial summary
The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Adenomatous Polyps
- What is being tested?
- Rectal biopsy during colonoscopy, Rectal biopsy at randomization and Rectal biopsy at 1 year
- Type of treatment
- Surgery or procedure
- How many people
- 264 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2006to Aug 2016
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the parent study examining the impact of calcium and vitamin D supplementation on the reoccurrence of colon polyps will be provided the opportunity to also participate in this adjunct biomarker study.
Who may be able to join
- 45 - 75 years old.
- ≥ 1 histologically-verified neoplastic polyps, ≥ 2 mm in diameter, removed from the large bowel within 4 months of study entry, with entire large bowel examined by colonoscopy and documented free of further polyps.
- Willing to follow the study protocol, as indicated by the subject's informed consent to participate.
- Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
- Anticipated colonoscopic follow up three years or five years after the qualifying colonoscopy.
Who cannot join
- Invasive carcinoma in any colonic polyp removed.
- Familial colonic polyposis syndromes.
- Ulcerative colitis or Crohn's disease.
- Malabsorption syndrome (e.g., pancreatic insufficiency).
- History of large bowel resection for any reason.
- Diagnosed narcotic or alcohol dependence.
Show all 20Show fewer
- Elevated serum calcium or creatinine, or supraphysiologic levels of 25(OH) vitamin D at study entry.
- Current use of thiazide diuretic in amount greater than the equivalent of 50 mg of hydrochlorothiazide.
- New York Heart Association Cardiovascular Disease functional class 3 or 4.
- On renal dialysis.
- History of kidney stones, unexplained hematuria, or sarcoidosis in the previous 20 years.
- Any history of hypo- or hyperparathyroidism.
- Unwilling to forgo individual calcium and vitamin D supplementation during the trial.
- Unwilling to forgo daily intake of more than a quart of milk (or equivalent in other dairy products) or daily dietary intake of vitamin D estimated to be greater than 400 IU.
- History of osteoporosis or other medical condition that may require supplemental calcium or vitamin D.
- Current use of bisphosphonates (eg, alendronate [Fosamax], risendronate [Actonel]).
- Current use of calcitonins (eg, Miacalcin).
- Additional exclusion criteria for the adjunct biomarker study are:
- Unable to be off aspirin for 7 days.
- History of bleeding disorder or current use of anticoagulant medication.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Emory University
Atlanta, Georgia, 30322
University of North Carolina
Chapel Hill, North Carolina, 27599
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Colorado Health Sciences Center
Denver, Colorado, 80220
University of Iowa Hospitals & Clinic
Iowa City, Iowa, 52242
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
USC/Norris Comprehensice Cancer Center
Los Angeles, California, 90089
University of Minnesota
Minneapolis, Minnesota, 55455
University of South Carolina
West Columbia, South Carolina, 29039
About this study
The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.
Read the detailed description
This study is an add-on study ('adjunct study') to a clinical trial that is already being conducted (the 'parent study'). Study participants will be composed of persons who are already participating in the parent study, "Vitamin D/Calcium Polyp Prevention Study". In the parent study, a total of 1,964 people nationally are being randomly assigned to four different treatment groups: 1) calcium supplements, 600 mg twice a day; 2) vitamin D supplements, 500 IU twice a day; 3) both the calcium and vitamin D supplements twice a day; and 4) placebo tablets twice a day. The treatment period lasts three to five years at the end of which study participants undergo a follow-up colonoscopy to look for new polyps. The parent study began about a year prior to the start of this adjunct study, thus, there are already some patients in the trial who are receiving their study 'treatments' (i.e., have been 'randomized'), but more patients will be recruited into the parent study.
Depending on whether someone has already been randomized, participants of the parent study will be invited to take part in the adjunct study in one of two ways: 'Aim 1' only, or 'All Aims'. First, patients who have already been randomized will be asked to allow biopsies to be made of their rectal tissue during their 3- or 5-year follow-up colonoscopy (Aim 1). Biopsies, which will be used for our biomarker measurements, are very tiny pieces of tissue that can be examined under the microscope. Second, patients who have not yet been randomized will be invited to participate more fully (All Aims) in the adjunct study. This involves having outpatient rectal biopsies taken immediately after their first phone call, their 1-year follow-up visit, and 7 - 21 days before their 3- or 5-year follow-up colonoscopy. Finally, during their 3- or 5-year colonoscopy, biopsies will be taken from three areas of the colon: the rectum (same area as the outpatient biopsies), the sigmoid colon, and the ascending colon. From all of the biopsies taken from all of the visits and colon sites, biomarker measurements will be of normal proteins that occur in the surface cells lining the colon. Study researchers will then analyze whether calcium and/or vitamin D affect these biomarkers and whether the effects predict who gets new polyps.
- Conditions
- Colorectal Adenomatous Polyps
- Being tested
- Rectal biopsy during colonoscopy, Rectal biopsy at randomization, Rectal biopsy at 1 year, Rectal biopsy prior to colonoscopy, Biopsies during colonoscopy
- Keywords
- colonic neoplasms, colorectal adenoma, calcium, vitamin D
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal biopsy during colonoscopyProcedure or surgery
Biopsies of rectal tissue will be obtained during the 3 or 5 year follow-up colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
Rectal biopsy at randomizationProcedure or surgery
Biopsies of rectal tissue will be obtained at the time of randomization. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
Rectal biopsy at 1 yearProcedure or surgery
Biopsies of rectal tissue will be obtained at the time of the one year follow-up visit. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
Rectal biopsy prior to colonoscopyProcedure or surgery
Biopsies of rectal tissue will be obtained 7-21 days prior to the 3 or 5 year colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn.
Biopsies during colonoscopyProcedure or surgery
Biopsies of the rectum, sigmoid colon and ascending colon will be obtained during the 3-5 year follow-up colonoscopy. The colonoscopy involves insertion of a flexible tube through the anus, which is then advanced the full length of the colon. Biopsies (tiny pinches of tissue less than 1/16 of an inch thick) will be taken as the colonoscopy tube is being removed. In total, 12-16 biopsies will be taken from the rectum (or lower colon about 3 - 4 inches up), sigmoid colon and ascending colon.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Participants previously randomized for the parent study will be eligible for a portion of the adjunct biomarker study. Receives: Procedure: Rectal biopsy during colonoscopy | |
| All aims | Participants entering the parent study will be eligible for all sample collections of the adjunct biomarker study. Receives: Procedure: Rectal biopsy at randomization; Procedure: Rectal biopsy at 1 year; Procedure: Rectal biopsy prior to colonoscopy; Procedure: Biopsies during colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
COX-2 Levels
Cyclo-oxygenase-2 (COX-2) is an enzyme that is elevated during periods of inflammation. Inflammation and inflammation regulation likely have important roles in colon cancer development. Control of inflammatory response suppresses COX-2.
Measured: Baseline to end of intervention (up to 5 years)
APC Protein Levels
Adenomatous polyposis coli (APC) is a protein encoded by the APC gene and is part of the APC Pathway of colon cancer development. The APC Pathway accounts for familial adenomatosis polyposis (FAP) and approximately 80% of sporadic cancers. The APC protein regulates β-catenin.
Measured: Baseline to end of intervention (up to 5 years)
β-catenin Levels
β-catenin is a protein encoded by the CTNNB1 gene and is part of the APC Pathway of colon cancer development. Overexpression and mutations of β-catenin are associated with multiple cancers, including colorectal cancer. An increase in the ratio of APC to β-catenin is indicative of a decrease of adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
E-cadherin Levels
E-cadherin is a calcium-dependent cell adhesion molecule necessary for colon crypt structure and function. Regulated by β-catenin, E-cadherin is part of the APC Pathway of colon cancer development. An increase in the ratio of APC to E-cadherin is indicative of a decrease of adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
MLH1 Protein Levels
MutL homolog 1 (MLH1) is a protein in the DNA Mismatch Repair (MMR) Pathway. MLH1 protein deficiencies have been found to be related multiple types of cancer, including colorectal cancer. The MMR Pathway accounts for hereditary non-polyosis colon cancer (HNPCC) and approximately 15% of sporadic cancers.
Measured: Baseline to end of intervention (up to 5 years)
Bax Levels
Bax (bcl-2-like protein 4) is a protein that promotes apoptosis of cancer cells and is involved in the DNA Mismatch Repair (MMR) Pathway. Apoptosis is higher in colon neoplasms than in normal colon tissue so a lower expression of bax is indicative of decreased adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
hTERT Levels
hTERT is a catalytic subunit of telomerase. Telomerase is normally present primarily in stem cells and at least some early daughter cells and is expressed in colon and other cancers. A decrease of hTERT is associated in decreased adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
Bcl-2 Levels
B-cell CLL/lymphoma 2 (bcl-2) is a protein encoded by the BCL2 gene which regulates apoptosis. Bcl-2 inhibits apoptosis of abnormal cells. A decrease in the ratio of bax to bcl-2 may be associated with a decrease in adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
TGFα Levels
Transforming growth factor alpha (TGFα), a potent stimulator of colonocyte growth/proliferation, can synergize with c-myc to promote malignant transformation in vitro. A decrease in the ratio of TGFα to TGFβ1 may be associated with a decrease in adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
TGFβ1 Levels
Transforming growth factor beta 1 (TGFβ1), a potent inhibitor of colonocyte growth/proliferation, inhibits c-myc19,26 and induces p21,26 and the growth suppressive activity of TGFβ1 is inhibited by β-catenin (part of the APC Pathway of colon cancer development). A decrease in the ratio of TGFα to TGFβ1 may be associated with a decrease in adenoma recurrence.
Measured: Baseline to end of intervention (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Roberd Bostick, MD, MPH, Emory University
- Investigators
- Roberd M Bostick, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399607
- Sponsor's protocol ID
- IRB00000357
- Other IDs
- R01CA114456, 0975-2005
- Acronym
- PPS4B
- Status last verified
- Dec 2016
- First submitted
- 13 Nov 2006
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention
- ClinicalTrials.gov ID
- NCT00399607
- Acronym / sponsor ID
- PPS4B / IRB00000357
- Conditions
- Colorectal Adenomatous Polyps
- Keywords
- colonic neoplasms, colorectal adenoma, calcium, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 15 Nov 2006 (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 study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.
Detailed description
This study is an add-on study ('adjunct study') to a clinical trial that is already being conducted (the 'parent study'). Study participants will be composed of persons who are already participating in the parent study, "Vitamin D/Calcium Polyp Prevention Study". In the parent study, a total of 1,964 people nationally are being randomly assigned to four different treatment groups: 1) calcium supplements, 600 mg twice a day; 2) vitamin D supplements, 500 IU twice a day; 3) both the calcium and vitamin D supplements twice a day; and 4) placebo tablets twice a day. The treatment period lasts three to five years at the end of which study participants undergo a follow-up colonoscopy to look for new polyps. The parent study began about a year prior to the start of this adjunct study, thus, there are already some patients in the trial who are receiving their study 'treatments' (i.e., have been 'randomized'), but more patients will be recruited into the parent study.
Depending on whether someone has already been randomized, participants of the parent study will be invited to take part in the adjunct study in one of two ways: 'Aim 1' only, or 'All Aims'. First, patients who have already been randomized will be asked to allow biopsies to be made of their rectal tissue during their 3- or 5-year follow-up colonoscopy (Aim 1). Biopsies, which will be used for our biomarker measurements, are very tiny pieces of tissue that can be examined under the microscope. Second, patients who have not yet been randomized will be invited to participate more fully (All Aims) in the adjunct study. This involves having outpatient rectal biopsies taken immediately after their first phone call, their 1-year follow-up visit, and 7 - 21 days before their 3- or 5-year follow-up colonoscopy. Finally, during their 3- or 5-year colonoscopy, biopsies will be taken from three areas of the colon: the rectum (same area as the outpatient biopsies), the sigmoid colon, and the ascending colon. From all of the biopsies taken from all of the visits and colon sites, biomarker measurements will be of normal proteins that occur in the surface cells lining the colon. Study researchers will then analyze whether calcium and/or vitamin D affect these biomarkers and whether the effects predict who gets new polyps.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | – | Procedure: Rectal biopsy during colonoscopyParticipants previously randomized for the parent study will be eligible for a portion of the adjunct biomarker study. |
| All aims | – | Procedure: Rectal biopsy at randomization, Procedure: Rectal biopsy at 1 year, Procedure: Rectal biopsy prior to colonoscopy, Procedure: Biopsies during colonoscopyParticipants entering the parent study will be eligible for all sample collections of the adjunct biomarker study. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the parent study examining the impact of calcium and vitamin D supplementation on the reoccurrence of colon polyps will be provided the opportunity to also participate in this adjunct biomarker study.
Key inclusion criteria (5 listed)
- 45 - 75 years old.
- ≥ 1 histologically-verified neoplastic polyps, ≥ 2 mm in diameter, removed from the large bowel within 4 months of study entry, with entire large bowel examined by colonoscopy and documented free of further polyps.
- Willing to follow the study protocol, as indicated by the subject's informed consent to participate.
- Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
- Anticipated colonoscopic follow up three years or five years after the qualifying colonoscopy.
Key exclusion criteria (20 listed)
- Invasive carcinoma in any colonic polyp removed.
- Familial colonic polyposis syndromes.
- Ulcerative colitis or Crohn's disease.
- Malabsorption syndrome (e.g., pancreatic insufficiency).
- History of large bowel resection for any reason.
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 |
|---|---|---|
| Rectal biopsy during colonoscopyBiopsies of rectal tissue will be obtained during the 3 or 5 year follow-up colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn. | Procedure or surgery | Aim 1 |
| Rectal biopsy at randomizationBiopsies of rectal tissue will be obtained at the time of randomization. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn. | Procedure or surgery | All aims |
| Rectal biopsy at 1 yearBiopsies of rectal tissue will be obtained at the time of the one year follow-up visit. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn. | Procedure or surgery | All aims |
| Rectal biopsy prior to colonoscopyBiopsies of rectal tissue will be obtained 7-21 days prior to the 3 or 5 year colonoscopy. The collection of rectal biopsies involves inserting a tube-about as long and big around as a doctor's examining finger-through the anus into the rectum or lower colon to a depth of about 3-4 inches. At this spot, 4 - 6 tiny pinches of tissue one mm thick (less than 1/16 of an inch) will be taken. The procedure takes less than two minutes, is painless (the only discomfort is like that of having a rectal exam), and is very low risk-about like having blood drawn. | Procedure or surgery | All aims |
| Biopsies during colonoscopyBiopsies of the rectum, sigmoid colon and ascending colon will be obtained during the 3-5 year follow-up colonoscopy. The colonoscopy involves insertion of a flexible tube through the anus, which is then advanced the full length of the colon. Biopsies (tiny pinches of tissue less than 1/16 of an inch thick) will be taken as the colonoscopy tube is being removed. In total, 12-16 biopsies will be taken from the rectum (or lower colon about 3 - 4 inches up), sigmoid colon and ascending colon. | Procedure or surgery | All aims |
Primary outcome
COX-2 Levels
Time frame: Baseline to end of intervention (up to 5 years)
Cyclo-oxygenase-2 (COX-2) is an enzyme that is elevated during periods of inflammation. Inflammation and inflammation regulation likely have important roles in colon cancer development. Control of inflammatory response suppresses COX-2.
APC Protein Levels
Time frame: Baseline to end of intervention (up to 5 years)
Adenomatous polyposis coli (APC) is a protein encoded by the APC gene and is part of the APC Pathway of colon cancer development. The APC Pathway accounts for familial adenomatosis polyposis (FAP) and approximately 80% of sporadic cancers. The APC protein regulates β-catenin.
β-catenin Levels
Time frame: Baseline to end of intervention (up to 5 years)
β-catenin is a protein encoded by the CTNNB1 gene and is part of the APC Pathway of colon cancer development. Overexpression and mutations of β-catenin are associated with multiple cancers, including colorectal cancer. An increase in the ratio of APC to β-catenin is indicative of a decrease of adenoma recurrence.
E-cadherin Levels
Time frame: Baseline to end of intervention (up to 5 years)
E-cadherin is a calcium-dependent cell adhesion molecule necessary for colon crypt structure and function. Regulated by β-catenin, E-cadherin is part of the APC Pathway of colon cancer development. An increase in the ratio of APC to E-cadherin is indicative of a decrease of adenoma recurrence.
MLH1 Protein Levels
Time frame: Baseline to end of intervention (up to 5 years)
MutL homolog 1 (MLH1) is a protein in the DNA Mismatch Repair (MMR) Pathway. MLH1 protein deficiencies have been found to be related multiple types of cancer, including colorectal cancer. The MMR Pathway accounts for hereditary non-polyosis colon cancer (HNPCC) and approximately 15% of sporadic cancers.
Bax Levels
Time frame: Baseline to end of intervention (up to 5 years)
Bax (bcl-2-like protein 4) is a protein that promotes apoptosis of cancer cells and is involved in the DNA Mismatch Repair (MMR) Pathway. Apoptosis is higher in colon neoplasms than in normal colon tissue so a lower expression of bax is indicative of decreased adenoma recurrence.
hTERT Levels
Time frame: Baseline to end of intervention (up to 5 years)
hTERT is a catalytic subunit of telomerase. Telomerase is normally present primarily in stem cells and at least some early daughter cells and is expressed in colon and other cancers. A decrease of hTERT is associated in decreased adenoma recurrence.
Bcl-2 Levels
Time frame: Baseline to end of intervention (up to 5 years)
B-cell CLL/lymphoma 2 (bcl-2) is a protein encoded by the BCL2 gene which regulates apoptosis. Bcl-2 inhibits apoptosis of abnormal cells. A decrease in the ratio of bax to bcl-2 may be associated with a decrease in adenoma recurrence.
TGFα Levels
Time frame: Baseline to end of intervention (up to 5 years)
Transforming growth factor alpha (TGFα), a potent stimulator of colonocyte growth/proliferation, can synergize with c-myc to promote malignant transformation in vitro. A decrease in the ratio of TGFα to TGFβ1 may be associated with a decrease in adenoma recurrence.
TGFβ1 Levels
Time frame: Baseline to end of intervention (up to 5 years)
Transforming growth factor beta 1 (TGFβ1), a potent inhibitor of colonocyte growth/proliferation, inhibits c-myc19,26 and induces p21,26 and the growth suppressive activity of TGFβ1 is inhibited by β-catenin (part of the APC Pathway of colon cancer development). A decrease in the ratio of TGFα to TGFβ1 may be associated with a decrease in adenoma recurrence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
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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.
Roberd M Bostick, MD, MPH principal investigator
Emory University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenomatous Polyps, run by Emory University at 9 sites 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COX-2 Levels (time frame: Baseline to end of intervention (up to 5 years)). The study lists 10 primary outcomes in all. 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 8 Dec 2016.