Colon CancerNCT00591279
Cancer Control Following Polypectomy
An observational study of Colon Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1981to Jan 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing colorectal cancer screening
Who may be able to join
- referral for colonoscopy or
- referral for proctoscopy or for a complete colonoscopy after a proctoscopy or flexible sigmoidoscopy
Who cannot join
- prior history of colon cancer, unrelated polypectomy, inflammatory bowel disease, family history of familial polyposis
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer
- Conditions
- Colon Cancer
- Keywords
- large bowel cancer, polyps, colorectal cancer
- Medical subject headings
- Colonic Neoplasms, Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Barium enema and colonoscopy at one and three years after entry. | |
| B | Barium enema and colonoscopy at three years only after entry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate strategies for the surveillance of post-polypectomy patients
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startFeb 1981
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mount Sinai Hospital, New York, Minneapolis Veterans Affairs Medical Center, Medical College of Wisconsin, St. Lukes hospital in Racine, Wiscousin, Massachusetts General Hospital, Cedars-Sinai Medical Center, Valley Presbyterian Hospital
- Responsible party
- Sponsor
- Investigators
- Sidney Winawer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591279
- Sponsor's protocol ID
- 81-035
- Status last verified
- Sep 2023
- First submitted
- 26 Dec 2007
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Control Following Polypectomy
- ClinicalTrials.gov ID
- NCT00591279
- Acronym / sponsor ID
- 81-035
- Conditions
- Colon Cancer
- Keywords
- large bowel cancer, polyps, colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mount Sinai Hospital, New York, Minneapolis Veterans Affairs Medical Center, Medical College of Wisconsin, St. Lukes hospital in Racine, Wiscousin, Massachusetts General Hospital, Cedars-Sinai Medical Center, Valley Presbyterian Hospital
- Study start
- Feb 1981 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Jan 2008 (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.
This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Barium enema and colonoscopy at one and three years after entry. |
| B | – | –Barium enema and colonoscopy at three years only after entry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing colorectal cancer screening
Key inclusion criteria (2 listed)
- referral for colonoscopy or
- referral for proctoscopy or for a complete colonoscopy after a proctoscopy or flexible sigmoidoscopy
Key exclusion criteria (1 listed)
- prior history of colon cancer, unrelated polypectomy, inflammatory bowel disease, family history of familial polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate strategies for the surveillance of post-polypectomy patients
Time frame: 6 years
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 13 Sep 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
Peritoneal (Metastatic) Cancer, Colorectal Cancer
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.
Sidney Winawer, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Colon Cancer, run by Memorial Sloan Kettering Cancer Center 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 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: finished, as of the sponsor's last update on 13 Sep 2023. 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 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?
evaluate strategies for the surveillance of post-polypectomy patients (time frame: 6 years). 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 13 Sep 2023.