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Trial record 13 of 484 for:    colon cancer | ( Map: Texas, United States )

Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02877056
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Research Foundation of the American Society of Colon and Rectal Surgeons
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment
Colorectal Cancer Procedure: Endoscopy

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


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Determinants of Response to Preoperative Therapy in Patients With Locally Advanced Colorectal Cancer
Actual Study Start Date : August 2005
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Colorectal Cancer
Participants undergo standard endoscopy before therapy. Tissue samples taken from the tumor and normal colorectal tissue.
Procedure: Endoscopy
Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.




Primary Outcome Measures :
  1. 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).


Biospecimen Retention:   Samples With DNA

Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy.

Up to eight biopsy samples of the tumor as well as up to six biopsies of the grossly normal colorectum obtained.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with Colorectal Cancer in the Gastrointestinal (GI) department at University of Texas MD Anderson Cancer Center.
Criteria

Inclusion Criteria:

  1. Patients with colorectal adenocarcinoma (diagnosis based on either MDACC or outside records)
  2. Patients scheduled to undergo neoadjuvant therapy per MDACC care team.
  3. Patients over 18 years of age.
  4. Patients with distant organ findings deemed to be indeterminate or metastatic will be enrolled at the surgeon's discretion.
  5. Patients who have been deemed medically safe to undergo endoscopic biopsy by the physician performing the procedure.
  6. 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.

Exclusion Criteria:

N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877056


Contacts
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Contact: Yi-Qian N. You, MD 713-792-6940 YNYou@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Research Foundation of the American Society of Colon and Rectal Surgeons
Investigators
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Principal Investigator: Yi-Qian N. You, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02877056     History of Changes
Other Study ID Numbers: LAB04-0962
R33 CA118505-01 ( Other Grant/Funding Number: American Society of Colon and Rectal Surgeons Research )
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Colorectal adenocarcinoma
Neoadjuvant therapy
Endoscopy
Endoscopic biopsy
Biomarkers
Genes
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases