Rectal CancerNCT00267787
Molecular Genetic and Pathological Studies of Anal Tumors
An observational study of Rectal Cancer and Colon Cancer, run by Stanford University at 1 site in United States.
Trial summary
Study the Genetics of Anal Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Colon Cancer, Colonic Neoplasms
- What is being tested?
- genetic analysis
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with anal cancer or high risk for anal cancer refered to Stanford.
Who may be able to join
- Patients with anal tumors
- Undergoing surgery for elective colon and rectal surgery Exclusion Criteria:No other patients other than adult patients with anal cancer or high risk for anal cancer refered to Stanford will be enrolled to the study. No Children will be included to the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Study the Genetics of Anal Cancer
Read the detailed description
To determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. Study of tissue samples and cells from biopsies of your lesion and blood sample. We hope to learn the role genes and proteins may play in the development of anal cancer. Experiments will be performed using this tissue and blood, include analysis of DNA, analysis of RNA expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.
- Conditions
- Rectal Cancer, Colon Cancer, Colonic Neoplasms, Anal Cancer
- Being tested
- genetic analysis
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic analysisOther
standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analysis of blood sample as well as tissues , will provide us with any possible tumor marker for a better prognostic indicator.
Measured: Annual assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2012
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Lane Welton, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267787
- Sponsor's protocol ID
- ANAL0001
- Other IDs
- 95340, ANAL0001, 14037
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2005
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetic and Pathological Studies of Anal Tumors
- ClinicalTrials.gov ID
- NCT00267787
- Acronym / sponsor ID
- ANAL0001
- Conditions
- Rectal Cancer, Colon Cancer, Colonic Neoplasms, Anal Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Dec 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.
Study the Genetics of Anal Cancer
Detailed description
To determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. Study of tissue samples and cells from biopsies of your lesion and blood sample. We hope to learn the role genes and proteins may play in the development of anal cancer. Experiments will be performed using this tissue and blood, include analysis of DNA, analysis of RNA expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with anal cancer or high risk for anal cancer refered to Stanford.
Key inclusion criteria (2 listed)
- Patients with anal tumors
- Undergoing surgery for elective colon and rectal surgery Exclusion Criteria:No other patients other than adult patients with anal cancer or high risk for anal cancer refered to Stanford will be enrolled to the study. No Children will be included to the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| genetic analysisstandard of care | Other | – |
Primary outcome
Genetic analysis of blood sample as well as tissues , will provide us with any possible tumor marker for a better prognostic indicator.
Time frame: Annual assessment.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Mark Lane Welton principal investigator
Stanford University
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 Rectal Cancer and Colon Cancer, run by Stanford University 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 0 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 10 Dec 2018. 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. 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?
Genetic analysis of blood sample as well as tissues , will provide us with any possible tumor marker for a better prognostic indicator. (time frame: Annual assessment.). 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 10 Dec 2018.