Colon CancerNCT00354705
Prognostic Molecular and Environmental Factors in High-Risk Colon Cancer Patients
An observational study of Colon Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing a recurrence (return) of colon cancer. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients 14 years of age and up with colon cancer recently removed by surgery and receiving chemotherapy to try to prevent cancer from returning.
Who may be able to join
- Histologically proven adenocarcinoma of the colon. Those patients that do not have tissue available at MDACC for analysis will be eligible to participate in the blood, questionnaire and data portion of the study. They will not participate in the tissue portion of this study.
- AJCC stage II [T3-4(subscript)N0(subscript)M0(subscript)]or stage III [TX(subscript)N1-3(subscript)M0(subscript)].
- Age >= 14 yrs old.
- If the patient elects to receive chemotherapy and it is to be administered outside of M. D. Anderson Cancer Center (MDACC), the patient must agree to complete all subsequent surveillance at M.D. Anderson Cancer Center if participating in this clinical trial.
- Ability to understand and the willingness to sign the written informed consent/authorization document.
Who cannot join
- Patients who have initiated adjuvant chemotherapy prior to participating in this study will not be included.
- Patients with known history of familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), and any other hereditary polyposis syndrome (Muir Torre, Gardner's Syndrome, etc) will be excluded since these patients are at increased risk for second primary malignancies and are at higher risk of recurrent disease.
- No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
- Patients with a known diagnosis of HIV/AIDS or Hepatitis C will be excluded from this study due to their increased risk of second primary malignancies that may complicate appropriate analysis of DFS.
- Patients who are unable to self-administer the protocol questionnaire will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients
The goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing a recurrence (return) of colon cancer.
Read the detailed description
Treatment with drugs (chemotherapy) and frequent evaluations by a doctor are standard practice to help prevent colon cancer from recurring after surgery. Despite these measures, the cancer does recur in a significant number of people, usually within the first 2-3 years from diagnosis.
In this study, researchers hope to identify genetic and environmental factors that may contribute to a person developing recurrent colon cancer. To help identify these factors, blood and tissue samples will be studied. You also will be asked to provide information about your background, lifestyle, and eating habits.
Participants able to take part in this study have had all of their known colon cancer removed by surgery and have agreed to receive chemotherapy to help prevent the cancer from recurring. Before you take part in this study, your medical information will be reviewed, and a performance status evaluation (how well you perform everyday activities) will be done. This will help the doctor decide if you are eligible to take part in the study.
If you are found to be eligible and you agree to take part in the study, you will be asked to fill out 2 questionnaires. One questionnaire asks about your background (age, education, etc.), work history, any exposure to toxic substances, medical history, smoking and alcohol history, family history of cancer, and your level of physical activity. The second questionnaire contains questions about what types of foods you eat, how often you eat them, whether you take vitamins and if so, what type(s). It will take about 30 minutes to fill out both of these questionnaires.
If your surgery to remove your colon cancer was not performed at MD Anderson, you will not be asked to participate in the tissue portion of this study described below but you will be asked to participate in the blood sample analysis and the study evaluations and questionnaire portion of this study every 3 months for a maximum of 2 years (starting from the beginning of the follow-up period, once all treatment is complete) or until your disease returns, which ever occurs first.
If your surgery was performed at MD Anderson Cancer Center, the samples of your cancer tissue will be analyzed, looking for any biologic factors related to colon cancer. Blood samples (about 4 teaspoons) for gene analysis (looking for any biologic factors associated with colon cancer) will also be collected.
Once follow-up begins, you will have study evaluations at MD Anderson every 3 months for 2 years or until your disease returns, which ever occurs first. Blood samples (about 4 teaspoons) for gene analysis will be collected within 14 days of completion of chemotherapy, and then every 3 months for 2 years after you enroll in this study. If your colon cancer recurs, a blood sample will be taken at that time also.
You will be asked to fill out the 2 questionnaires described above at the completion of your chemotherapy treatment (if applicable) and 1 and 2 years after your follow-up begins. If your colon cancer recurs, you will be asked to fill out the questionnaires at that time.
If you require surgery for cancer after enrolling in this study, a sample of leftover tissue will be collected for genetic analysis if the surgery is performed at MD Anderson Cancer Center.
You will not be informed of any results of the analysis of your blood and tumor samples or the questionnaires, as this research is exploratory. Your participation in this study will end if your disease returns or 2 years after you begin, whichever occurs first.
This is an investigational study. Taking part in this study requires that you return frequently to MD Anderson. Up to 200 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Colon Cancer
- Being tested
- Questionnaire
- Keywords
- Colon Cancer, Adenocarcinoma of the Colon, Cancer Recurrence, Survey, Chemotherapy, Surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Two questionnaires taking 30 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Colon Cancer Patients | Patients with colon cancer recently removed by surgery. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Recurrent Colon Cancer
Study endpoint is occurrence of recurrent colon carcinoma determined radiologically and/or histologically.
Measured: Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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 M.D. Anderson 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cathy Eng, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354705
- Sponsor's protocol ID
- 2005-0383
- Status last verified
- May 2019
- First submitted
- 18 Jul 2006
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Molecular and Environmental Factors in High-Risk Stage II and Stage III Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT00354705
- Acronym / sponsor ID
- 2005-0383
- Conditions
- Colon Cancer
- Keywords
- Colon Cancer, Adenocarcinoma of the Colon, Cancer Recurrence, Survey, Chemotherapy, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2006 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Jul 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 goal of this research study is to identify biologic and lifestyle factors that may increase a person's risk of developing a recurrence (return) of colon cancer.
Detailed description
Treatment with drugs (chemotherapy) and frequent evaluations by a doctor are standard practice to help prevent colon cancer from recurring after surgery. Despite these measures, the cancer does recur in a significant number of people, usually within the first 2-3 years from diagnosis.
In this study, researchers hope to identify genetic and environmental factors that may contribute to a person developing recurrent colon cancer. To help identify these factors, blood and tissue samples will be studied. You also will be asked to provide information about your background, lifestyle, and eating habits.
Participants able to take part in this study have had all of their known colon cancer removed by surgery and have agreed to receive chemotherapy to help prevent the cancer from recurring. Before you take part in this study, your medical information will be reviewed, and a performance status evaluation (how well you perform everyday activities) will be done. This will help the doctor decide if you are eligible to take part in the study.
If you are found to be eligible and you agree to take part in the study, you will be asked to fill out 2 questionnaires. One questionnaire asks about your background (age, education, etc.), work history, any exposure to toxic substances, medical history, smoking and alcohol history, family history of cancer, and your level of physical activity. The second questionnaire contains questions about what types of foods you eat, how often you eat them, whether you take vitamins and if so, what type(s). It will take about 30 minutes to fill out both of these questionnaires.
If your surgery to remove your colon cancer was not performed at MD Anderson, you will not be asked to participate in the tissue portion of this study described below but you will be asked to participate in the blood sample analysis and the study evaluations and questionnaire portion of this study every 3 months for a maximum of 2 years (starting from the beginning of the follow-up period, once all treatment is complete) or until your disease returns, which ever occurs first.
If your surgery was performed at MD Anderson Cancer Center, the samples of your cancer tissue will be analyzed, looking for any biologic factors related to colon cancer. Blood samples (about 4 teaspoons) for gene analysis (looking for any biologic factors associated with colon cancer) will also be collected.
Once follow-up begins, you will have study evaluations at MD Anderson every 3 months for 2 years or until your disease returns, which ever occurs first. Blood samples (about 4 teaspoons) for gene analysis will be collected within 14 days of completion of chemotherapy, and then every 3 months for 2 years after you enroll in this study. If your colon cancer recurs, a blood sample will be taken at that time also.
You will be asked to fill out the 2 questionnaires described above at the completion of your chemotherapy treatment (if applicable) and 1 and 2 years after your follow-up begins. If your colon cancer recurs, you will be asked to fill out the questionnaires at that time.
If you require surgery for cancer after enrolling in this study, a sample of leftover tissue will be collected for genetic analysis if the surgery is performed at MD Anderson Cancer Center.
You will not be informed of any results of the analysis of your blood and tumor samples or the questionnaires, as this research is exploratory. Your participation in this study will end if your disease returns or 2 years after you begin, whichever occurs first.
This is an investigational study. Taking part in this study requires that you return frequently to MD Anderson. Up to 200 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon Cancer Patients | – | Behavioral: QuestionnairePatients with colon cancer recently removed by surgery. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 14 years of age and up with colon cancer recently removed by surgery and receiving chemotherapy to try to prevent cancer from returning.
Key inclusion criteria (5 listed)
- Histologically proven adenocarcinoma of the colon. Those patients that do not have tissue available at MDACC for analysis will be eligible to participate in the blood, questionnaire and data portion of the study. They will not participate in the tissue portion of this study.
- AJCC stage II [T3-4(subscript)N0(subscript)M0(subscript)]or stage III [TX(subscript)N1-3(subscript)M0(subscript)].
- Age >= 14 yrs old.
- If the patient elects to receive chemotherapy and it is to be administered outside of M. D. Anderson Cancer Center (MDACC), the patient must agree to complete all subsequent surveillance at M.D. Anderson Cancer Center if participating in this clinical trial.
- Ability to understand and the willingness to sign the written informed consent/authorization document.
Key exclusion criteria (5 listed)
- Patients who have initiated adjuvant chemotherapy prior to participating in this study will not be included.
- Patients with known history of familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), and any other hereditary polyposis syndrome (Muir Torre, Gardner's Syndrome, etc) will be excluded since these patients are at increased risk for second primary malignancies and are at higher risk of recurrent disease.
- No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
- Patients with a known diagnosis of HIV/AIDS or Hepatitis C will be excluded from this study due to their increased risk of second primary malignancies that may complicate appropriate analysis of DFS.
- Patients who are unable to self-administer the protocol questionnaire will be excluded from this study.
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 |
|---|---|---|
| QuestionnaireAlso: SurveyTwo questionnaires taking 30 minutes to complete. | Behavioural | Colon Cancer Patients |
Primary outcome
Occurence of Recurrent Colon Cancer
Time frame: Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.
Study endpoint is occurrence of recurrent colon carcinoma determined radiologically and/or histologically.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Cathy Eng, MD principal investigator
M.D. Anderson 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 M.D. Anderson 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 5 inclusion and 5 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 10 May 2019. 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?
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?
Occurence of Recurrent Colon Cancer (time frame: Information collected at 1, 2 and 3 years after completion of adjuvant chemotherapy or at the time of reoccurrence.). 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 May 2019.