Colorectal CancerNCT01196130
Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs. This is an investigational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cancer Symptom Questionnaire and Biomarker Testing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,275 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 9 Dec 2022
- 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: Patients previously treated with systemic chemotherapy for metastatic colorectal cancer.
Who may be able to join
- The patient has a histologically or cytologically confirmed colorectal adenocarcinoma with metastatic or unresectable, locally advanced disease documented on diagnostic imaging studies.
- The patient must have been previously treated with systemic chemotherapy for metastatic or unresectable, locally advanced colorectal cancer, with no limit on the number of prior regimens. Patients who develop recurrent or metastatic disease on or within 6 months of adjuvant therapy are eligible.
- Age >/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal cancer.
- ECOG performance status 0-2.
- The patient has signed informed consent.
Who cannot join
- 1) Inability to comply with study and/or follow-up procedures.
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: Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol
The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs.
This is an investigational study. This study's biomarker testing is for research purposes only.
Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Read the detailed description
The effectiveness of drugs used to treat colorectal cancer may be different from person to person. Researchers want to learn if certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer.
Study Participation:
If you agree to take part in this study, the following tests and procedures will be performed:
- A leftover sample of tumor tissue from a previous procedure, if available, will be used for biomarker testing.
- Blood (about 3 tablespoons) will be drawn for biomarker testing, to check for levels of cytokines (proteins that may affect the immune system), and to check the circulating tumor cells (CTCs) in your blood.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
You will also fill out a questionnaire about the cancer symptoms. This should take about 5 minutes.
Biomarker Test Results:
The study doctor and staff will review the biomarker test results with you.
If the results seem to show that a certain investigational drug may help to control the cancer, and the drug is available through a separate MD Anderson clinical research study called a "companion" drug study, your doctor may recommend that you have additional tests and procedures performed. The tests and procedures will be performed as part of the companion drug study to see if you are eligible to receive that drug. You will be asked to sign a separate consent form for the companion drug study.
It is possible that the biomarker test results may seem to show that more than one drug may help to control the cancer. If so, it may be possible that you could receive the other drug(s) under other companion studies in the future. The study tests described below would be repeated during those other studies as well.
Even if the biomarker testing shows that a certain drug may be helpful, it is possible that you may not be eligible to take part in the separate companion drug study, the study drug may not be available, or there may be other reasons you cannot take part in the drug study. You may also decide that you do not want to take part in the companion drug study. Your doctor will discuss other available treatment options with you.
Study Visits:
At study visits for this biomarker research study, the following tests and procedures will be performed:
- You will fill out the cancer symptom questionnaire.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.
Your schedule of study visits will depend on whether or not you take part in a companion study. There is a different schedule of visits for participants who do not take part in a companion study but instead either take part in a clinical research study that is not a companion study or they receive standard cancer drug(s).
If you take part in 1 or more companion studies, you will have study visits for this biomarker research study on the following schedule:
- before you start taking the drug(s) if you join a companion drug study and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
- each time you return for imaging scans during the time that you take part in 1 or more companion drug studies
- after you stop taking part in a companion drug study
If your first treatment after consenting to this biomarker research study is part of a clinical research study that is not a companion study or if you receive standard cancer drug(s), you will have study visits for this biomarker research study on the following schedule:
- before you start taking the drug(s) during your first treatment period at MD Anderson and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
- each time you return for imaging scans during your first treatment period at MD Anderson
- after you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s).
Length of Treatment:
The study testing will continue:
- for as long as you are taking part in a companion drug study, or
- until you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s), if you do not take part in a companion drug study.
Follow-Up Visit:
If you stop taking part in this study:
- You will fill out the cancer symptom questionnaire.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.
Long-Term Follow-Up:
After your follow-up visit, from then on, the research staff will collect information on your health status, the drug(s) you receive, and the status of the disease. This information may be collected at the time of standard clinic visits, by reviewing your medical record and imaging scans, and/or by contacting you by phone, mail, and/or email. If you are called, the call will last about 10 minutes or less.
- Conditions
- Colorectal Cancer
- Being tested
- Cancer Symptom Questionnaire, Biomarker Testing
- Keywords
- Metastatic colorectal cancer, CRC, Colorectal adenocarcinoma, Biomarker determination, Tumor tissue, Treatment protocols
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Symptom QuestionnaireBehavioural
5 minute questionnaire(s) completed at each study visit.
Biomarker TestingOther
Blood draw at each study visit for biomarker and cytokine testing.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker Assessment | Leftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms. Receives: Behavioral: Cancer Symptom Questionnaire; Other: Biomarker Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Biomarker Determination
Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.
Measured: +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startAug 2010
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Scott Kopetz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196130
- Sponsor's protocol ID
- 2009-0091
- Other IDs
- R01CA172670, RP110584, NCI-2017-00505
- Status last verified
- Dec 2022
- First submitted
- 3 Sep 2010
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Overman MJ, Morris V, Kee B, Fogelman D, Xiao L, Eng C, Dasari A, Shroff R, Mazard T, Shaw K, Vilar E, Raghav K, Shureiqi I, Liang L, Mills GB, Wolff RA, Hamilton S, Meric-Bernstam F, Abbruzzese J, Morris J, Maru D, Kopetz S. Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials. Ann Oncol. 2016 Jun;27(6):1068-1074. doi: 10.1093/annonc/mdw073. Epub 2016 Feb 18.
PubMed 27045102
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol
- ClinicalTrials.gov ID
- NCT01196130
- Acronym / sponsor ID
- 2009-0091
- Conditions
- Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, CRC, Colorectal adenocarcinoma, Biomarker determination, Tumor tissue, Treatment protocols
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2010 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 8 Sep 2010 (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 clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs.
This is an investigational study. This study's biomarker testing is for research purposes only.
Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Detailed description
The effectiveness of drugs used to treat colorectal cancer may be different from person to person. Researchers want to learn if certain biomarkers can be used to help predict which cancer drugs may work better than other drugs in different people with colorectal cancer.
Study Participation:
If you agree to take part in this study, the following tests and procedures will be performed:
- A leftover sample of tumor tissue from a previous procedure, if available, will be used for biomarker testing.
- Blood (about 3 tablespoons) will be drawn for biomarker testing, to check for levels of cytokines (proteins that may affect the immune system), and to check the circulating tumor cells (CTCs) in your blood.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
You will also fill out a questionnaire about the cancer symptoms. This should take about 5 minutes.
Biomarker Test Results:
The study doctor and staff will review the biomarker test results with you.
If the results seem to show that a certain investigational drug may help to control the cancer, and the drug is available through a separate MD Anderson clinical research study called a "companion" drug study, your doctor may recommend that you have additional tests and procedures performed. The tests and procedures will be performed as part of the companion drug study to see if you are eligible to receive that drug. You will be asked to sign a separate consent form for the companion drug study.
It is possible that the biomarker test results may seem to show that more than one drug may help to control the cancer. If so, it may be possible that you could receive the other drug(s) under other companion studies in the future. The study tests described below would be repeated during those other studies as well.
Even if the biomarker testing shows that a certain drug may be helpful, it is possible that you may not be eligible to take part in the separate companion drug study, the study drug may not be available, or there may be other reasons you cannot take part in the drug study. You may also decide that you do not want to take part in the companion drug study. Your doctor will discuss other available treatment options with you.
Study Visits:
At study visits for this biomarker research study, the following tests and procedures will be performed:
- You will fill out the cancer symptom questionnaire.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.
Your schedule of study visits will depend on whether or not you take part in a companion study. There is a different schedule of visits for participants who do not take part in a companion study but instead either take part in a clinical research study that is not a companion study or they receive standard cancer drug(s).
If you take part in 1 or more companion studies, you will have study visits for this biomarker research study on the following schedule:
- before you start taking the drug(s) if you join a companion drug study and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
- each time you return for imaging scans during the time that you take part in 1 or more companion drug studies
- after you stop taking part in a companion drug study
If your first treatment after consenting to this biomarker research study is part of a clinical research study that is not a companion study or if you receive standard cancer drug(s), you will have study visits for this biomarker research study on the following schedule:
- before you start taking the drug(s) during your first treatment period at MD Anderson and it has been 2 or more weeks since you had these tests done (note: the amount of blood drawn will be about 2 tablespoons at this visit)
- each time you return for imaging scans during your first treatment period at MD Anderson
- after you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s).
Length of Treatment:
The study testing will continue:
- for as long as you are taking part in a companion drug study, or
- until you first stop taking part in a clinical research study that is not a companion drug study, or until you first stop taking standard cancer drug(s), if you do not take part in a companion drug study.
Follow-Up Visit:
If you stop taking part in this study:
- You will fill out the cancer symptom questionnaire.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for biomarker, cytokine, and CTC testing.
Long-Term Follow-Up:
After your follow-up visit, from then on, the research staff will collect information on your health status, the drug(s) you receive, and the status of the disease. This information may be collected at the time of standard clinic visits, by reviewing your medical record and imaging scans, and/or by contacting you by phone, mail, and/or email. If you are called, the call will last about 10 minutes or less.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker Assessment | – | Behavioral: Cancer Symptom Questionnaire, Other: Biomarker TestingLeftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated with systemic chemotherapy for metastatic colorectal cancer.
Key inclusion criteria (5 listed)
- The patient has a histologically or cytologically confirmed colorectal adenocarcinoma with metastatic or unresectable, locally advanced disease documented on diagnostic imaging studies.
- The patient must have been previously treated with systemic chemotherapy for metastatic or unresectable, locally advanced colorectal cancer, with no limit on the number of prior regimens. Patients who develop recurrent or metastatic disease on or within 6 months of adjuvant therapy are eligible.
- Age >/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal cancer.
- ECOG performance status 0-2.
- The patient has signed informed consent.
Key exclusion criteria (1 listed)
- 1) Inability to comply with study and/or follow-up procedures.
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 |
|---|---|---|
| Cancer Symptom Questionnaire5 minute questionnaire(s) completed at each study visit. | Behavioural | Biomarker Assessment |
| Biomarker TestingBlood draw at each study visit for biomarker and cytokine testing. | Other | Biomarker Assessment |
Primary outcome
Rate of Successful Biomarker Determination
Time frame: +/- 7 days
Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.
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 Dec 2022.
- Derived from this study: PubMed 27045102Overman MJ, Morris V, Kee B, Fogelman D, Xiao L, Eng C, Dasari A, Shroff R, Mazard T, Shaw K, Vilar E, Raghav K, Shureiqi I, Liang L, Mills GB, Wolff RA, Hamilton S, Meric-Bernstam F, Abbruzzese J, Morris J, Maru D, Kopetz S. Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials. Ann Oncol. 2016 Jun;27(6):1068-1074. doi: 10.1093/annonc/mdw073. Epub 2016 Feb 18.
- 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.
Scott Kopetz, 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 Colorectal 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 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 Dec 2022. 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?
Rate of Successful Biomarker Determination (time frame: +/- 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196130, which also lists 1 linked publication.
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 Dec 2022.