Colorectal CancerNCT02877056
Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
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 laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy. This is an investigational study. Up to 350 patients will take part in this 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?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2023
- 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: Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.
Who may be able to join
- Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
- Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
- Patients over 18 years of age.
- Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
- Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
- Patients who would have typically undergone preoperative therapy followed by surgery but for specific reasons at the discretion of the treating physician underwent surgery without preoperative therapy may be enrolled at the surgeons' discretion.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy.
This is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Patients with colorectal cancer usually receive radiation, chemotherapy, or other therapy before they have surgery. At this time, there are no tests that can help researchers find out which patients no longer have any tumor left after completing treatment. Because of this, all patients have to have surgery to completely remove the rectum and/or part of the colon. This procedure results in lifestyle changes for the patient, which may be difficult and permanent.
Researchers are looking for new ways to find out which patients will have no tumor left after treatment, so that in the future, some patients may be able to avoid surgery altogether. In this study, researchers will try to use chemical "markers" in tumor cells as a way to possibly predict whether or not the tumor is likely to disappear with treatment alone.
At MD Anderson, all patients with colorectal cancer have an endoscopy performed by their surgeon as part of standard care, before they start therapy. Endoscopy involves placing a narrow tube in the colon and/or rectum in order to see and inspect the tumor.
If you choose to take part in this study, tissue samples will be taken from the tumor and the normal areas during your standard endoscopy. If you undergo surgery, tissue samples from the tumor(s) and normal areas will also be collected. At the time of endoscopy and/or surgery, once the doctor has finished all standard tests on this tissue and has received the clinical reports on these tests, any leftover tissue samples will be collected by Dr. You or a person on her research team for research tests to look for tumor cell "markers." Researchers want to find out how these markers may have changed since you began receiving treatment for the disease.
Some of the tissue from your biopsies may also be sent to the labs at University of Texas-Southwest or Natera for testing. No identifying information about you will be included with these samples. They will have a special number assigned, so that the samples being sent to UT Southwest or Natera will not be able to be connected to you in any way.
The results of these tests will not be used to make any decisions regarding treatment of your rectal cancer. There are no other tests or procedures required in this study
- Conditions
- Colorectal Cancer
- Being tested
- Endoscopy
- Keywords
- Colorectal adenocarcinoma, Neoadjuvant therapy, Endoscopy, Endoscopic biopsy, Biomarkers, Genes
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer | Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer
Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startAug 2005
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation of the American Society of Colon and Rectal Surgeons
- Responsible party
- Sponsor
- Investigators
- Yi-Qian N. You, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877056
- Sponsor's protocol ID
- LAB04-0962
- Other IDs
- R33 CA118505-01
- Status last verified
- May 2019
- First submitted
- 17 Aug 2016
- Last updated
- 29 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 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02877056
- Acronym / sponsor ID
- LAB04-0962
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal adenocarcinoma, Neoadjuvant therapy, Endoscopy, Endoscopic biopsy, Biomarkers, Genes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Research Foundation of the American Society of Colon and Rectal Surgeons
- Study start
- Aug 2005 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Aug 2016 (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 laboratory research is to look for genes that can predict which patients will achieve a complete disappearance of their colorectal cancer after treatment like chemotherapy, radiation, or other therapy.
This is an investigational study. Up to 350 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Patients with colorectal cancer usually receive radiation, chemotherapy, or other therapy before they have surgery. At this time, there are no tests that can help researchers find out which patients no longer have any tumor left after completing treatment. Because of this, all patients have to have surgery to completely remove the rectum and/or part of the colon. This procedure results in lifestyle changes for the patient, which may be difficult and permanent.
Researchers are looking for new ways to find out which patients will have no tumor left after treatment, so that in the future, some patients may be able to avoid surgery altogether. In this study, researchers will try to use chemical "markers" in tumor cells as a way to possibly predict whether or not the tumor is likely to disappear with treatment alone.
At MD Anderson, all patients with colorectal cancer have an endoscopy performed by their surgeon as part of standard care, before they start therapy. Endoscopy involves placing a narrow tube in the colon and/or rectum in order to see and inspect the tumor.
If you choose to take part in this study, tissue samples will be taken from the tumor and the normal areas during your standard endoscopy. If you undergo surgery, tissue samples from the tumor(s) and normal areas will also be collected. At the time of endoscopy and/or surgery, once the doctor has finished all standard tests on this tissue and has received the clinical reports on these tests, any leftover tissue samples will be collected by Dr. You or a person on her research team for research tests to look for tumor cell "markers." Researchers want to find out how these markers may have changed since you began receiving treatment for the disease.
Some of the tissue from your biopsies may also be sent to the labs at University of Texas-Southwest or Natera for testing. No identifying information about you will be included with these samples. They will have a special number assigned, so that the samples being sent to UT Southwest or Natera will not be able to be connected to you in any way.
The results of these tests will not be used to make any decisions regarding treatment of your rectal cancer. There are no other tests or procedures required in this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer | – | Procedure: EndoscopyParticipants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.
Key inclusion criteria (6 listed)
- Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
- Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
- Patients over 18 years of age.
- Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
- Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| EndoscopyTissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy. | Procedure or surgery | Colorectal Cancer |
Primary outcome
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer
Time frame: 1 day
Tissue taken at endoscopy undergoes testing for tumor cell biomarkers to identify patients who achieve complete response (CR).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Yi-Qian N. You, 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 6 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: status not confirmed, as of the sponsor's last update on 29 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?
Contact Yi-Qian N. You, MD (713-792-6940, YNYou@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Tumor Cell Biomarkers After Chemoradiation Treatment for Colorectal Cancer (time frame: 1 day). 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 29 May 2019.